Handling Reagent Packs on the Atellica® IM Analyzer Job Aid

Handling Reagent Packs on the Atellica® IM Analyzer Job Aid SIEMENS Healthineers The IM Analyzer uses primary and ancillary shaped reagent packs. • All assays use a primary size pack • Some assays require one or more additional reagents in ancillary size packs - refer to the Instructions for Use (IFU) o The Reagent Needs screen will indicate if additional ancillary reagents need to be loaded o If there is an ancillary size reagent included in the package with the primary reagent it is a required reagent. These have test codes that end in "A" o Other ancillary sized reagents include probe washes, sample diluents, and releasing agents. The need for probe washes is based on the interdependence of the onboard assays o Humidity packs also use ancillary spots in the reagent compartment The IM reagent compartment is designed to hold: • 42 primary reagent packs • 42 ancillary reagent packs o 7 or 10 of these positions will be taken by humidity packs NOTE: The Instructions for Use (IFU) includes a list of all associated ancillary reagents. Some of these ancillary reagents are optional. The IFU’s can be found in Document Library. 1 Template Effective Date: 10 Aug 2021 | HILS 2223 Effective Date: 22-DEC-2021 | HOOD05162003247295 Unrestricted © Siemens Healthineers, 2021 Handling Reagent Packs on the Atellica® IM Analyzer Job Aid SIEMENS Healthineers Depending on the assay, IM reagents may be packaged in: Single packs A A. B. Kitted packs – depending on the assay, may include ancillary SIEMENS reagent/calibrators/QC material, in addition to primary reagent Healthineers Atellico" IM For USA RxOnly For in vitro dagrossc use in the quantitative PSA measurement of prostate cdc andoen in human • For kitted packs, primary and ancillary reagents should be loaded Serum using the Asetica " IM Analyzer For Professional Use Contains: Lhe Finagant 10.0 ml: Solid Phase 25.0 mil and unloaded together. If a primary reagent is automatically F/ 100 737 unloaded, the operator may need to manually unload the ReadyPack* --- - - corresponding ancillary reagent Refer to IFU for the following reagent handling instructions: • Preparation B • Storage Atetlica" IM SIEMENS VitD Healthineers • Stability Medico IM! VitD 20.0 ml Auttico IM VitD CAL VItD CAL Ready Packe ft NOTE: There are select assays that require lot locked ancillary reagents 20 which are not included in the kit. Refer to the IFU. 2 Effective Date: 22-DEC-2021 | HOOD05162003247295 Unrestricted © Siemens Healthineers, 2021 Handling Reagent Packs on the Atellica® IM Analyzer Job Aid SIEMENS Healthineers NOTE: During off-system storage, solid phase particles settle as a pellet at the bottom of the primary reagent pack. 1. If shutting down the analyzer reagent compartment refrigeration for longer than 2 hours, remove and store the reagent packs A. Cover the pierced film area of the reagent pack with self- sealing laboratory film T4 Contains: I Reagent 10.0 mw hase 25.0 ml @ 150 x Je Diagnostics tor 511 Benedict B. Store any off-system reagent packs at 2-8 C ReadyPack" --- ◦ C. Before loading primary reagent packs onto the system, manually mix the packs to re-suspend the particles homogeneously D. Return the reagent packs to the system when the reagent compartment temperature is 2-8 ◦ C E. Verify reagent performance based on acceptable QC results or laboratory criteria 2. If the analyzer has not mixed reagent packs for 30 minutes or longer, remove all primary reagent packs and manually mix NOTE: If the reagent compartment is out of temperature range for greater than 60 before resuming normal operations. Refer to the IFU minutes, the system will flag results using those reagents as Reagent Compartment Temperature. 3 Effective Date: 22-DEC-2021 | HOOD05162003247295 Unrestricted © Siemens Healthineers, 2021 Handling Reagent Packs on the Atellica® IM Analyzer Job Aid SIEMENS Healthineers Preparing Ancillary Reagents at High Altitude 3 Ancillary packs raised to high altitudes can leak a small amount of fluid when the aspiration port is pierced. With some fluid leaked out, the expected volume is different than the actual volume in the pack. If your laboratory is at an altitude greater than 350(m) or 1148 (ft) Atellicar IM VitD Before placing all filled ancillary packs onboard the Atellica IM analyzer: Puncture 1. Ensure you are wearing appropriate PPE (Personal Protective Do not puncture fill port aspirate port Equipment), including protective glasses and gloves 2. Place the ancillary reagent pack on a flat surface 3. Obtain a disposable pipette tip and puncture the fill port. Do not puncture the aspiration port 4. Place a replacement seal (SMN 11208742) over the puncture hole 4 5. Ensure that all QC results are within the laboratory acceptable range before releasing or reporting patient results teltica" IM VitD ----- 6 ml NOTE: It is important to ensure there is no contamination when piercing the fill port seal by using a disposable tip. Do not reuse pipette tips to avoid reagent carryover from one ancillary pack to another. 4 Effective Date: 22-DEC-2021 | HOOD05162003247295 Unrestricted © Siemens Healthineers, 2021 SIEMENS Healthineers Please note that the learning material is for training purposes only! For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator's Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. Atellica, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability varies by country and is subject to varying regulatory requirements. Please contact your local representative for availability. © Siemens Healthcare GmbH 2021 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 5 siemens-healthineers.com Effective Date: 22-DEC-2021 | HOOD05162003247295 Unrestricted © Siemens Healthineers, 2021