Thermo Scientific BRAHMS KRYPTOR compact PLUS Скачать руководство пользователя страница 41

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Kimby Barton, Interim Director, Medical Devices Bureau/Directrice intérimaire, Bureau des matériels médicaux

_________________________________________________________

* AMENDED *

* MODIFIÉE *

No d'homologation:

96541

Licence Number:

Première date de délivrance:

2016/02/12

First Issue Date:

2017/01/16

Application Number:

Numéro de la demande:

263153

116875

Manufacturer ID:

Identificateur du fabricant:

Date de modification:

Amended Date:

La présente homologation est délivrée en vertu

de l'article 36 du Règlement sur les instruments

médicaux pour l'instrument médical suivant:

This Licence is issued in accordance with the

Medical Devices Regulations, Section 36,

for the following medical device:

Device Class/Classe de l'instrument: 2

16761

GERMANY

HENNIGSDORF

NEUENDORFSTRASSE 25

Manufacturer Name & Address/Nom du fabricant & adresse

BRAHMS GMBH

ADDITION OF DEVICES

Reason for Amendment/Raison de la modification

BRAHMS KRYPTOR

Licence Name/Nom de l'homologation:

Licence Type/Type d'homologation:

System / Système

Therapeutic Products Directorate

Medical Devices Bureau

Direction des produits thérapeutiques

Bureau des matériels médicaux

96541

LN/NH:

Santé Health

Canada Canada

Homologation d'un instrument médical

Medical Device Licence

Содержание BRAHMS KRYPTOR compact PLUS

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Страница 10: ...B R A H M S KRYPTOR compact PLUS User Manual Version R08 106172 I SW 7 06 00 I Date 21 02 2018 ...

Страница 11: ...81 B R A H M S KRYPTOR compact SOLUTION 2 89982 B R A H M S KRYPTOR compact SOLUTION 3 89983 B R A H M S KRYPTOR compact SOLUTION 4 89984 B R A H M S KRYPTOR compact DILCUP 89985 B R A H M S KRYPTOR compact REACT 89986 B R A H M S KRYPTOR compact PLUS Instrument and consumables Content changes versus previous version Add new laser labels Add UDI USA Rx only and cTUVus labels Add information about ...

Страница 12: ...ousel 14 Reagent Area 15 Reaction Area 16 Dilution Plate 16 B R A H M S KRYPTOR compact SOLUTIONS 1 to 4 17 Fluidic System 17 Routine Work 18 Start up 18 Maintenance 18 Reagent registration 19 Reconstitution of reagents 19 Perform a calibration 19 Run controls 20 Run patient samples with barcode 20 End of day 20 Analytes with Pre incubation 21 Important User Information 23 Barcodes Specifications ...

Страница 13: ...ng Caution Class 3B invisible laser radiation when open and interlocks defeated Avoid exposure to the beam Location on side panel access to the laser Laser light Do not stare into the beam Class 2 laser product Location on fluidic hood Symbol Explanation Serial number of Reading Module Serial number of Pipetting Module Identification of the machine Alternative current AC Humidity range Temperature...

Страница 14: ...he assembly Barcode that provides UDI information according to FDA regulations Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner applicable to USA classification only cTUVus logo 106172 USA Rx only Labelling of B R A H M S KRYPTOR compact SOLUTIONS SGH 05 Corrosion SGH 07 Exclamation Mark ...

Страница 15: ...e accessible Transport conditions 20 70 C Long term storage 0 50 C Input and output connections Caution On the serial communication ports connect only a RS 232 link Very low safety voltage On the USB port connect only the specific USB cable provided Very low safety voltage On Waste bottle cap liquid level and mechanical sensor connect only the specific cable provided Very low safety voltage Electr...

Страница 16: ...usel barcode reader Class 2 laser and the manual barcode reader do not look at the laser Avoid direct eye exposure Class 2 lasers are limited to a maximum output power of 1 milliwatt and the beam must have a wavelength between 400 and 700 nm A person receiving an eye exposure from a Class 2 laser beam either accidentally or as a result of someone else s deliberate action mis use will be protected ...

Страница 17: ...ample is excited with a nitrogen laser at 337 nm the donor emits a long life fluorescent signal in the milli second range at 620 nm while the acceptor generates a short life signal in the nanosecond range at 665 nm or 707 nm depending on the type of acceptor When the two components are bound in an immuno complex both the signal amplification and the prolong ed life span of the acceptor signal occu...

Страница 18: ...ection system to aspirate all components required to perform the biological analysis This includes the sample diluent and reagents After aspirating the sample and reagent components into the tip the tip is heated to reac tion temperature and acts as a pre reaction incuba tor This ensures that the fluids are at reaction tem perature before dispensing in to the reaction area At the end of dispense t...

Страница 19: ... A H M S KRYPTOR compact REACT and its life onboard the instrument is monitored by the software through a barcode placed on each reaction plate and transpa rent damper closing The reaction plate is heated at 37 C 0 5 C Handheld barcode reader All relevant information concerning calibrators con trols reagent lots and reaction plate barcodes are registered on B R A H M S KRYPTOR compact PLUS by the ...

Страница 20: ... TOOL BAR WINDOWS COMMAND BAR WINDOWS START BUTTON WINDOWS TASK BAR STATUS BAR B R A H M S KRYPTOR compact PLUS WORK SURFACE 7 2 3 4 5 6 1 Waste Distilled or demineralized water Liquid system Buffer PBS Phosphate Buffer Saline Wash liquid B R A H M S KRYPTOR compact Wash Solutions Dilution plates Sample tray Reagents tray Reaction plate 8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 1 2 3 4 6 5 7 8 ...

Страница 21: ...ork Analysis INSTRUMENT Rescan Carousel Start Processing Pause Processing Query All Prime Reconstitute Kits Reaction Plate Sample Carousel Reagents REGISTRATION Calibrator Standard Control Reagent Lot ADMINISTRATION Panels Analytes Combined Analytes Reflex Testing User Accounts Instrument Params LIS Interface Preferences HELP User Manual About These menus are available by clicking on The main menu...

Страница 22: ...t Data Results Data QC Functions Registration Reagent Lot Registration Calibrator Standard Instrument Prime Instrument Reconstitute Kits Help Instrument Reaction Plate System Logon System Shutdown DESCRIPTION Identification of samples without starting a run This icon disappears after click on it to give access to Pause processing This icon appears after Processing has started Addition of more samp...

Страница 23: ...ated clot insufficient sample volume Red with a white point sample during pipetting process with at least one test with problem Work Surface Colour Codes Sample Carousel At the end of carousel scan all samples with a barcode and tests in the worklist will be shown in green blue yellow or red If the system is connected to LIS there are different colours for the sample status see Administration Menu...

Страница 24: ...dicates the number of remaining tests Double clicking anywhere in the reagent area opens the Reagent Status window This window enables you to display information about each reagent kit installed in the reagent area of the instrument and to request calibration for each reagent kit TEMPERATURE BAR ON THE REAGENT AREA Green 2 0 8 0 C Blue 2 0 C Red 8 0 C or communication failed Yellow one or more rea...

Страница 25: ...fter 7 days the plate is automatically unloaded at the next end of day first ready or initialized stage after midnight Time validity status of reaction plate is available when clicking with the left mouse button on the reaction plate on the screen If there is an xy position error the plate is automatically unloaded and cannot be used any more Pipetting sequence does not start if the reaction area ...

Страница 26: ...reen OK Yellow Take care to change the bottle soon solution expires tomorrow Red Bottle to be replaced dead volume reached or solution expired Fluidic System An intermediate tank system enables you to refill B R A H M S KRYPTOR BUFFER or distilled demineralized water bottle when red status is detected without stopping the current run by use of dead volume in intermediate tank system If the dead vo...

Страница 27: ...en Ensure the reagent lid is well closed After an automatic change of day The automatic change of day procedure is launched every day on the first ready or intialized stage after midnight This will perform automatically all the initializations init pipetor init reader Nevertheless the user will have a logon to perform manual maintenances and database maintenance User is warned that he has to logon...

Страница 28: ...d open the fluidic hood and check if tip can be slightly bent to enter the hole Reagent registration For the following working steps installation of valid version of K DISK ANA is needed Necessary when using new lots only Reagent Click on Reagent Lot Manager Click on Register Scan the barcode sheet Click on OK and confirm the registration with Yes Calibrator Click on Calibrator Standard Manager Cl...

Страница 29: ...p Select Save sample and continue with required samples Close Request a carousel hood opening by pressing on blue button in front of carousel part Place sample tubes on the carousel making sure the barcode fills the slot Close the carousel hood Start the instrument Results Open results list Select a test It is possible to Cancel tests in detecting or counting step or in pending only in Ready statu...

Страница 30: ...when the reagent kit has no tests remaining in Phase I however the RED square can remain active if other tests in Phase I are under way If the buffer bottle water bottle one of the solution bottles or the waste bottle is detected in red status during Phase I or Phase II pipetting will stop and a popup window on interface informs to replace the solution In Phase II the carousel hood will be opened ...

Страница 31: ...n R08en Page 22 of 30 During Phase I tests appear in blue with the message pre incubating The start time of a test is given after the start of Phase II If the test is failed during Phase I the test is indicated in red with an alarm System error Pre incubation has failed ...

Страница 32: ...a consumable is loaded by manual entry it is marked by a symbol not reaction plate and on session log If during a scan a barcode is detected in place of manual entry ID scan reading has priority ID con sumable detected by scan erases manual entry ID This action is indicated in session log Interface drawing of tray positioning may differ from actual tray position For manual entry make sure that pla...

Страница 33: ...tion should be done on tube clot removal or sample tube change before to launching new tests Case 2 Clot could not be released tip is blocked This popup appears to inform that pipetting sequence is stopped with carrousel hood open Tip cleaning after fatal clot detection Open fluidic hood place tip on Zhome position Clean point of tip Unscrew tubing on tip liquid must flow out into wash bowl Discon...

Страница 34: ...rast is not sufficient B A B Available symbologies on KRYPTOR instruments Code 128 Code 39 Codabar Code 2 5 interleaved Code UPC EAN Other specifications Minimum resolution 0 21 mm size of narrowest bar black or white bar Minimum ratio 2 5 ratio of narrow bars to wide bars Maximum ratio 3 0 Silence section blank section before and after the code at least 10 times the resolution a silent section be...

Страница 35: ...rs sporadically while a significant work list is loaded on B R A H M S KRYPTOR compact PLUS the problem is not relevant It is then advisable to relaunch the sample displaying this message 11 System Warning Late TE If the problem occurs more than once in a series shut down and then restart the instrument after 1 or 2 minutes If the problem persists launch an intervention If the problem persists cal...

Страница 36: ...ror Above max Range Relaunch the test manually with a small dilution factor 1 2 or 1 5 38 Data Warning Calibrator Warning Start a calibration not later than the following day 39 Data Warning Below Normal Information that sample is below the cut off 40 Data Warning Above Normal Information that sample is above the cut off 42 Concentration not Consistent with Dilution Used Relaunch the test with ano...

Страница 37: ...wells avail able will be managed as usual Plexi Door The Plexi door is the clear flap which is lowered when loading a new reaction plate The soft ware no longer identifies if it is open or closed Check that the plexi door is closed before loading the reaction plate to prevent damage to the reaction plate carriage Reader Front Door This door is used to load the reaction plate and the software no lo...

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Страница 39: ...106228 8 Find out more at thermoscientific com kryptor 49 0 3302 883 0 49 0 3302 883 100 fax info brahms thermofisher com www thermoscientific com brahms Thermo Fisher Scientific B R A H M S GmbH Neuendorfstr 25 16761 Hennigsdorf Germany Clinical Diagnostics B R A H M S GmbH Neuendorfstr 25 16761 Hennigsdorf Germany 49 3302 883 0 49 3302 883 100 fax info brahms thermofisher com www thermoscientifi...

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Страница 41: ...nstruments médicaux pour l instrument médical suivant This Licence is issued in accordance with the Medical Devices Regulations Section 36 for the following medical device Device Class Classe de l instrument 2 16761 GERMANY HENNIGSDORF NEUENDORFSTRASSE 25 Manufacturer Name Address Nom du fabricant adresse BRAHMS GMBH ADDITION OF DEVICES Reason for Amendment Raison de la modification BRAHMS KRYPTOR...

Страница 42: ...ue Device ID No de l instrument 813304 82591 BRAHMS PCT SENSITIVE KRYPTOR QC Device Identifier Identificateur de l instrument Model Catalog Detail No de modèle Catalogue Device ID No de l instrument 813305 82592 BRAHMS CGA II KRYPTOR Device Identifier Identificateur de l instrument Model Catalog Detail No de modèle Catalogue Device ID No de l instrument 815670 839 050 BRAHMS CGA II KRYPTOR CAL Dev...

Страница 43: ...vice Identifier Identificateur de l instrument Model Catalog Detail No de modèle Catalogue Device ID No de l instrument 823276 85392 BRAHMS ANTI TPON KRYPTOR Device Identifier Identificateur de l instrument Model Catalog Detail No de modèle Catalogue Device ID No de l instrument 823277 852 075 BRAHMS ANTI TPON KRYPTOR CAL Device Identifier Identificateur de l instrument Model Catalog Detail No de ...

Страница 44: ...vice Identifier Identificateur de l instrument Model Catalog Detail No de modèle Catalogue Device ID No de l instrument 823282 801 050 BRAHMS TRAK HUMAN KRYPTOR CAL Device Identifier Identificateur de l instrument Model Catalog Detail No de modèle Catalogue Device ID No de l instrument 823283 80191 BRAHMS TRAK HUMAN KRYPTOR QC Device Identifier Identificateur de l instrument Model Catalog Detail N...

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Страница 46: ...tem Common Name Inflammatory Response Marker Classification Name Antigen Inflammatory Response Marker Sepsis 21 CFR 866 3210 Predicate Device Manufacturer Product Name 510 k No BR A H M S Aktiengesellschaft B R A H M S PCT LIA K040887 Device Description The BR A H M S PCT sensitive KRYPTOR assay is a homogeneous sandwich immunoassay for detection of PCT in human serum or plasma The B R A H M S KRY...

Страница 47: ...tor signal occur at 665 nm and the life is in the microsecond range This delayed acceptor signal is proportional to the concentration of the analyte to be measured The specific fluorescence which is proportional to the antigen concentration is obtained through a double selection spectral separation depending on wave length and temporal time resolved measurement This enables an exclusive measuremen...

Страница 48: ...hich is the same for both devices The monoclonal antibody used in both devices binds to Katacalcin For the second antibody the B R A H M S PCT sensitive KRYPTOR uses a polyclonal antibody which is directed against Calcitonin The B R A H M S PCT LIA uses a monoclonal antibody directed against Calcitonin instead of a polyclonal antibody Although the antibodies directed against Calcitonin come from d...

Страница 49: ... the general population such as in asthma and or COPD patients Method Comparison Summary The B R A H M S PCT sensitive KRYPTOR and the B R A H M S PCT LIA both detect procalcitonin PCT in human serum or plasma A correlation study was performed in accordance with CLSI guideline EP9 A Method Comparison and Bias Estimation Using Patient Samples between the B R A H M S PCT sensitive KRYPTOR assay and ...

Страница 50: ... categorized according to the criteria of the consensus conference of the American College of Chest Physicians Society of Critical Care Medicine PCT should always be interpreted in the clinical context of the patient Therefore clinicians should use the PCT results in conjunction with other laboratory findings and clinical signs of the patient Data support the following interpretative risk assessme...

Страница 51: ...mends the use of only one matrix i e use the same material either serum or plasma EDTA or heparin throughout the patient s clinical course It is recommended that citrate plasma not be used since concentrations were underestimated with citrate plasma CLSI guidelines should be followed for collecting transporting and processing patient samples The sample volume needed for an assay is 50 PI Testing d...

Страница 52: ...ubject to the general controls provisions of the Act The general controls provisions of the Act include requirements for annual registration listing of devices good manufacturing practice labeling and prohibitions against misbranding and adulteration If your device is classified see above into either class II Special Controls or class III PMA it may be subject to such additional controls Existing ...

Страница 53: ...7 For questions regarding postmarket surveillance please contact CDRH s Office of Surveillance and Biometric s OSB s Division of Postmarket Surveillance at 240 276 3474 For questions regarding the reporting ofdevice adverse events Medical Device Reporting MDR please contact the Division of Surveillance Systems at 240 276 3464 You may obtain other general information on your responsibilities under ...

Страница 54: ...assay The B R A H M S PCT sensitive KRYPTOR is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock Prescription Use And Or Over The Counter Use _ 21 CFR 801 Subpart D 21 CFR 807 Subpart C Do Not Write Below This Line Cont...

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Страница 56: ...ass III medical device or Class IIb medical device that is an implantable medical device the distribution records shall be retained for a minimum period of 10 years In the case of records relating to any other device the distribution records shall be retained for a minimum period of 5 years The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log of inf...

Страница 57: ...k s Product Specific Conditions No specific conditions have been recorded against this entry Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia Phone 1800 020 653 Email info tga gov au ARTG Identifier 190292 ARTG Start Date 7 10 2011 ...

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