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Quidel Triage MeterPro, Руководство пользователя

"Quidel Triage MeterPro" - компактный прибор для быстрого анализа биологических образцов. Прост в использовании, надежен и точен. Для полной информации по настройке и использованию загрузите бесплатное руководство пользователя с нашего сайта manualshive.com. Узнайте больше об этом удивительном приборе прямо сейчас!

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Page

72

of

86

additional

reagents.

Each

device

contains

a

full

complement

of

reagents

that

are

required

to

perform

the

immunoassay.

The

Quidel

Triage

tests

have

been

designed

to

include

assay

controls

in

each

test

device

that

monitor

the

assay

procedure

and

the

reagent

integrity.

The

assay

controls

present

a

unique

and

valuable

extension

to

the

traditional

approach

to

quality

control

using

liquid

reagents.

If

the

product

is

stored

under

specified

conditions,

proper

functioning

of

the

assay

controls

indicates

that

the

test

device

is

valid

and

proper

adherence

to

assay

protocol

has

been

followed.

The

assay

controls

in

the

Quidel

Triage

tests

require

the

need

to

re

Ͳ

think

the

frequency

with

which

external

quality

control

specimens

should

be

tested.

The

Quidel

Triage

tests

have

been

designed

to

yield

long

Ͳ

term

reagent

stability.

In

addition,

the

system

provides

quality

control

parameters

in

three

separate

and

distinct

categories:

„

Internal

device

controls

„

Meter

electronic

controls

„

Software

controls.

The

combination

of

these

quality

control

features

provides

more

information

about

the

validity

of

each

assay

than

can

be

provided

by

the

more

traditional

methods

of

reagent

and

assay

procedure

validation.

Quality

Assurance

Functions

1.

Internal

Device

Quality

Assurance

„

Internal

Positive

Control

Zone

„

Baseline

Control

Zone

„

Timing

Control

Zone

„

Zone

Quality

Requirements

(Trace

QC)

2.

Meter

Quality

Assurance

„

Self

Ͳ

Test

Mode

„

Internal

Calibration

Chip

„

Electronic

QC

Device

„

Bar

Code

3.

Software

Quality

Assurance

„

Supervisor

CODE

CHIP

module

„

User

ID#

„

Patient

ID#

„

Result

memory

storage

„

QC

Frequency

„

QC

Lockouts

4.

Quality

Control

Samples

Internal

Device

Quality

Assurance

The

Internal

Control

Zones

are

built

Ͳ

in

functional

immunoassays.

This

control

verifies

that

the

device

functioned

properly

and

that

the

assay

was

correctly

performed.

The

Internal

Positive

Control

Zone

ensures

that

the

antibodies,

the

reagent

reconstitution,

the

timegate

and

the

device

flow

are

functioning

properly.

The

manufacturer

sets

acceptable

ranges

for

the

control

zones

for

each

lot

of

reagents.

The

Baseline

Control

Zone

monitors

the

presence

of

interfering

substances

in

the

patient

sample

that

may

alter

the

immunoassay

process.

If

a

specimen

contains

a

substance

that

has

a

major

effect

on

the

high

and

Содержание Triage MeterPro

Страница 1: ...Page 1 of 86 User Manual...

Страница 2: ...lation 15 Unpack Meter 15 Power Meter On 15 Install Paper 16 Insert Supervisor Code Chip Module 17 To Change Meter Settings 17 Change Clock 19 Set User ID 20 Change Reference Ranges Thresholds for Tes...

Страница 3: ...Purpose 49 Function 49 Last Record 49 Patient Results 50 Patient ID 50 Test Device Lot Number L N 51 User ID 52 From Date 52 Till Date 53 QC Results 54 QC Sample Lot Number L N 55 Device Lot Number L...

Страница 4: ...ning 70 Check Battery Level 70 Battery Replacement 70 Total Quality Assurance 71 Introduction 71 Quality Assurance Functions 72 Internal Device Quality Assurance 72 Meter Quality Assurance 73 Software...

Страница 5: ...ebsite quidel com If outside the U S contact local distributor or one of the Technical Support centers listed below You may also contact us at quidel com Region Phone E mail Address Europe and Middle...

Страница 6: ...er ID Ranges Clock Meter Settings Test Settings QC Parameters Bypass x New User ID x Update User ID x Delete User ID x User ID List x QC Device Freq x QC Sample Freq x Number of Controls x Num Quant S...

Страница 7: ...urer In vitro diagnostic medical device Consult instructions for use Authorized representative in the European Community Temperature limitation Humidity limitation Waste electrical and electronic equi...

Страница 8: ...Control Calibration Verification Prescription use only Contents contains Expected values Biological risks Thaw Transfer pipette Mean Standard deviation CODE CHIP module Printer Paper Peel open here A...

Страница 9: ...n use Do NOT write or place a label anywhere on the QC device as it may interfere with the device functionality Do not move the Quidel Triage MeterPro while a test is in progress Ensure all sample flu...

Страница 10: ...Installation Guides the user through first time setup Section 4 Operation Guides the user through running tests recalling results and deleting results Section 5 Service and Maintenance Procedures Pap...

Страница 11: ...d Quality Control QC functions that allow the person operating the meter to monitor quality control Unpacking The Quidel Triage MeterPro and the items that come with it are provided in a single box Qu...

Страница 12: ...e and CODE CHIP module in the QC Device box AC DC Power Converter AA Batteries Rolls of Printer Paper additional rolls are supplied in each box of test devices Supervisor CODE CHIP module and CODE CHI...

Страница 13: ...Page 13 of 86 Parts of the Quidel Triage MeterPro...

Страница 14: ...result on paper Data Port Connection point for the optional Bar Code Scanner allowing the operator to scan patient or user identification data instead of manually entering numbers or letters on the k...

Страница 15: ...When the test is completed the screen meter display will come to rest at the main menu Low Power Indicator 8 23AM 01 20 18 Time and date Menu items User Instructions RUN TEST RECALL RESULTS INSTALL NE...

Страница 16: ...details about Installing Paper see the Care and Maintenance section b Tear or cut a clean straight edge to feed into the printer Do not cut paper at an angle as the printer must sense the edge of the...

Страница 17: ...t The port is located on the left side of the meter towards the bottom front corner Note the orientation of the CODE CHIP module in the drawing below d Once the Supervisor CODE CHIP module is installe...

Страница 18: ...ACTERS MISC ID Min 1 Max 20 1 20 1 20 AUX ID ENABLE DISABLE Disabled Disabled Enabled For reference record your settings in the space provided e Press the key to save changes to ID Settings Display Se...

Страница 19: ...and press the key b Select CLOCK using the keys and press the key c Select the HOUR MINUTE area using the keys Type in the correct time using the number keys d Press the key to move to AM or PM e Sele...

Страница 20: ...e keys Type in the new value for the HIGH or LOW cutoff as appropriate e Press the key to save changes For more details about Ranges Settings see page 33 Change Test Settings a Select SET PARAMETERS u...

Страница 21: ...the keys d Press the key to save changes to the Bypass setting For more details about Bypass Settings see page 36 Prior to commencing patient testing remove the Supervisor CODE CHIP module from the me...

Страница 22: ...e information is transferred into the Quidel Triage MeterPro s memory A CODE CHIP module typically needs to be installed only once and remains in the meter memory A CODE CHIP module does not need to r...

Страница 23: ...or Disable Auxiliary ID Number of Characters in Misc Test ID DISPLAY SETTINGS Language Printer Mode Auto Power Off Display Contrast Printer Contrast COMMUNICATIONS Baud Rate Enable or Disable LIS Enab...

Страница 24: ...see a list of programmable parameters METER SETTINGS CLOCK USER ID RANGES TEST SETTINGS QC PARAMETERS BYPASS SELECT WITH v OR AND PRESS ENTER OR PRESS EXIT The Set Parameters Menu 4 Use the keys to se...

Страница 25: ...X column 8 Use the keys to choose the largest number of characters that will appear in the User ID The maximum number of characters possible is 16 9 Press the key to save changes Characters Pat ID Thi...

Страница 26: ...aracters that will appear in the Auxiliary ID The maximum number of characters possible is 12 9 Press the key to save changes Aux ID Enable Disable This setting will turn on or turn off the Auxiliary...

Страница 27: ...rgest number of characters that will appear in the MISC TEST ID The maximum number of characters possible is 20 9 Press the key to save changes Display Settings Language This setting will determine wh...

Страница 28: ...Power Off 6 Use the keys to choose the desired timer setting for the meter to power itself off when not in use The choices are 1 2 HOUR 1 HOUR 2 HOURS 4 HOURS or NONE If NONE is selected the meter mus...

Страница 29: ...n entered will allow data to be transmitted Baud Rate 1 1 1 1 From a list of programmable parameters choose METER SETTINGS using the keys 2 Press the key 3 Use the keys to select COMM SETTINGS 4 Press...

Страница 30: ...S Enable 1 From a list of programmable parameters choose METER SETTINGS using the keys 2 Press the key 3 Use the keys to select COMM SETTINGS 4 Press the key 5 Use the keys to select LIS 6 Use the key...

Страница 31: ...o the DATE 9 Using the keypad type in the 6 digit date according to the DATE FORMAT below it 10 Press to move to the DATE FORMAT 11 Use the keys to select MM DD YY DD MM YY or YY MM DD The previously...

Страница 32: ...er ID you want to update To correct press to clear the entire ID or select the incorrect character by using the keys Then type in the correct ID 6 Press the key 7 The user ID is displayed with the exp...

Страница 33: ...ing the month number the day number and the year number in the format you have chosen The numbers you type will appear from the right and move left as you continue to type To correct press to clear th...

Страница 34: ...upervisor may wish to control which tests are available to be run at the time of patient testing The options are 1 ACTIVE ACTIV ON SCREEN The test is always run and cannot be deselected 2 INACTIVE INA...

Страница 35: ...tive tests is 2 or 3 standard deviations QC Device Frequency The QC DEVICE FREQUENCY setting determines the maximum interval between QC Device tests that a user is allowed to run patient tests When th...

Страница 36: ...ts 1 From the list of programmable parameters choose QC PARAMETERS using the keys 2 Press the key 3 Use the keys to select the information to the right of NUM QUANT STD DEVS 4 Using the keys select on...

Страница 37: ...mple CODE CHIP module included in each box of controls Lot number begins with a C QC Device CODE CHIP module included in the black QC Device box comes with the Quidel Triage MeterPro and is labeled wi...

Страница 38: ...rPro s memory 6 Press to return to acknowledge the message 7 Remove the CODE CHIP module from the CODE CHIP module Port 8 Place the CODE CHIP module back into its original container for storage INSTAL...

Страница 39: ...software upgrade Supervisor Installation Procedure Otherwise No restriction SET PARAMETERS Access Control Supervisor Programmable Settings Supervisor DELETE RESULTS Patient Test Results Supervisor Unl...

Страница 40: ...day of patient testing To run the QC Device test 1 Press the key to power the Quidel Triage MeterPro on 2 Select RUN TEST using the keys 3 Press the key 4 Type in your identification User ID To corre...

Страница 41: ...e a printed copy of the results 13 Remove the QC Device from the Meter and place in the QC Device Box DO NOT DISCARD THE QC DEVICE IMPORTANT Important instructions for all tests a Gently insert the te...

Страница 42: ...idel QC Sample To run the Quality Control sample 1 Press the key to power the Quidel Triage MeterPro on 2 Select RUN TEST using the keys 8 23AM 01 20 18 RUN TEST RECALL RESULTS INSTALL NEW CODE CHIP S...

Страница 43: ...mpt to pull it out The device may be ejected by returning to the Main Menu and pressing EXIT 12 Repeat steps for each quality control sample IMPORTANT Important instructions for QC Sample Tests D If t...

Страница 44: ...correct press to clear the entire ID or select the incorrect character by using the keys Then type in the correct ID 5 Press the key 6 Select PATIENT SAMPLE using the keys PATIENT SAMPLE QC DEVICE QC...

Страница 45: ...st device has been pulled into the meter the meter will display a message similar to the following SELECT TESTS CARDIAC CKMB 2 MYO 3 TNI PRESS TO PAUSE OR 0 9 FOR TEST PRESS ENTER TO CONTINUE OR EXIT...

Страница 46: ...he Main Menu and pressing EXIT IMPORTANT Important instructions for patient tests a If the test device s Internal Quality Control QC results are unacceptable the results for the affected analyte s wil...

Страница 47: ...TEST SELECT WITH v OR AND PRESS ENTER PRESS EXIT TO EJECT DEVICE 7 Press the key 8 Type or scan the Misc Test identification Misc Test ID To correct press to clear the entire ID or select the incorre...

Страница 48: ...has been inserted properly b Press the key to start the test c The Quidel Triage MeterPro pulls in the test device and scans it d When the test is complete the meter will beep and display the results...

Страница 49: ...talled to view the full User ID Last Record Purpose Last Record is used to retrieve the test results for the last test run To retrieve the last record 1 Press the key to power the Quidel Triage MeterP...

Страница 50: ...the selected panel will be displayed For individual patient results a Select Patient ID using the keys b Type or scan in the patient ID To correct press the key to clear the entire ID or select the i...

Страница 51: ...to select the desired panel 10 Select DEVICE L N using the keys 11 To display all results for the selected panel press the key 12 To display results specific to one lot type in the lot number of the t...

Страница 52: ...press the key 12 To display results specific to one User ID type in the User ID To correct press to clear the entire ID or select the incorrect character by using the keys Then type in the correct ID...

Страница 53: ...e selected panel are displayed 15 Use the keys to view the entire record 16 Press the key to make a printed copy 17 Press the key to upload the selected results to LIS Till Date To retrieve results fr...

Страница 54: ...s of these quality control QC tests can be retrieved from the Quidel Triage MeterPro s memory Quality Control QC test Results can be retrieved by QC Sample Results Panel Type QC Sample Lot Number L N...

Страница 55: ...press to clear the entire number Then type in the correct number 12 Press the key 13 All results from test run on the requested QC Sample lot number for the selected panel are displayed 14 Use the key...

Страница 56: ...ve QC results from tests run on the Quidel Triage MeterPro starting with the user you select 1 Press the key to power the Quidel Triage MeterPro on From the MAIN MENU select RECALL RESULTS using the k...

Страница 57: ...he entire number Then type in the correct number 12 Press the key 13 All results from tests run from the date selected for the selected panel if QC Sample are displayed 14 Use the keys to view the ent...

Страница 58: ...ackground If the QC for the lot has failed the word FAILED will appear in place of an expiration date If a CODE CHIP has been installed for a new lot but QC has yet to be established the words NOT RUN...

Страница 59: ...Select MISC TEST ID using the keys b Type or scan in the Misc Test ID To correct press the key to clear the entire ID or select the incorrect character by using the keys Then type in the correct ID c...

Страница 60: ...the keys 9 To display all results for the selected panel press the key 10 To display results specific to one lot type in the lot number of the test device To correct press the key to clear the entire...

Страница 61: ...incorrect character by using the keys Then type in the correct ID 11 Press the key 12 All results from tests run by the requested user for the selected panel are displayed 13 Use the keys to view the...

Страница 62: ...power the Quidel Triage MeterPro on 2 From the MAIN MENU select RECALL RESULTS using the keys 3 Press the key 4 Select MISC TEST RESULTS using the keys 5 Press the key 6 Select PANEL TYPE using the k...

Страница 63: ...to clear the entire ID or select the incorrect character by using the keys Then type in the correct ID 9 Press the key to make a printed copy QC Sample Results To print all QC Sample Results 1 Press...

Страница 64: ...SULTS using the keys 5 Press the key 6 Select MISC TEST RESULTS using the keys 7 Press the key to make a printed copy Upload Results to LIS When interfaced directly to an LIS selecting this feature wi...

Страница 65: ...XXX MORE RECORDS PRESS ENTER The Memory Alert Screen IMPORTANT The Delete function permanently removes all patient data from the meter memory Before continuing you may wish to first print results or u...

Страница 66: ...want to delete all patient results press the key Display Backlight The Quidel Triage MeterPro has the capability for the operator to backlight the display for providing improved clarity depending on a...

Страница 67: ...o alpha character is displayed 6 M N O The first press of a button causes the first letter to be displayed The second press of the same button within three seconds causes the second letter to be displ...

Страница 68: ...er at an angle as the printer must sense the edge of the paper along the feed path 5 Insert the new roll of paper into the paper compartment 6 Position the paper such that the paper will feed from und...

Страница 69: ...Position the paper such that the paper will feed from under the roll as opposed to over the top of the roll see picture above 7 Insert the paper edge under the paper roller platen until it firmly seat...

Страница 70: ...th front and back of the door Check Battery Level The Quidel Triage MeterPro checks the active power source after ejecting a device or printing To check the battery power navigate to the MAIN MENU dis...

Страница 71: ...which analytical methods are traditionally controlled is through the use of liquid control specimens containing known amounts of analytes Over the last 15 years advances in technology have changed th...

Страница 72: ...ontrol features provides more information about the validity of each assay than can be provided by the more traditional methods of reagent and assay procedure validation Quality Assurance Functions 1...

Страница 73: ...izontal and vertical alignment of the zone measurement to verify laser alignment and device transport The QC Device also confirms laser stability A Bar Code is printed on the bottom of every test devi...

Страница 74: ...r Total Quality Assurance features inherent in the Quidel Triage tests The Quidel Triage tests have been designed to maximize Total Quality Assurance in any testing environment The combination of the...

Страница 75: ...the RECALL RESULTS menu 5 Supervisor Access To prevent misuse the Supervisor CODE CHIP module is required for access to the SET PARAMETERS and DELETE RESULTS functions of the software The Supervisor C...

Страница 76: ...iode Memory Capacity 750 Patient Records 32 Reagent Lot CODE CHIP modules 200 QC Sample Results 200 QC Sample CODE CHIP modules 70 QC Device Results 4 QC Device CODE CHIP modules 250 Misc Test Results...

Страница 77: ...ced Contact Quidel CODE CHIP module will not fit in meter a CODE CHIP module may have been inserted upside down a Re insert CODE CHIP module right side up b CODE CHIP module or Meter contacts could be...

Страница 78: ...e eliminates the message the original CODE CHIP is at fault discard CODE CHIP module b Meter error b If the new CODE CHIP module does not work install a known working CODE CHIP module to verify proper...

Страница 79: ...ed when the meter has been without power Press the ENTER key QC Device calibration alignment or laser failed Messages Calib Pass or Fail Laser Pass or Fail Align Pass or Fail a May be due to lint or d...

Страница 80: ...nd Electronic Equipment WEEE Appendix D Glossary Analyte Chemical substance being measured Assay Test Calibration Comparison of result to a reference standard Character One part of a longer string of...

Страница 81: ...Device Not all Quidel Triage test panels have the MMX feature Parameters Options functions Photodiode Detects the light emitted from the fluorescent dye in the test devices used in the Quidel Triage...

Страница 82: ...DE CHIP module used to download new software onto the Quidel Triage MeterPro Supervisor CODE CHIP module The CODE CHIP module that allows a supervisor to set parameters and delete results Test device...

Страница 83: ...Page 83 of 86...

Страница 84: ...Page 84 of 86...

Страница 85: ...Page 85 of 86...

Страница 86: ...l Triage MeterPro MDSS GmBH Schiffgraben 41 30175 Hannover Germany Quidel Cardiovascular Inc 9975 Summers Ridge Drive San Diego CA 92121 USA quidel com ENSRC26611enA PN 26611en Rev A 2018 03 Revision...

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