Reagent Handling on the Atellica® CI Analyzer Job Aid

Reagent Handling on the Atellica® CI Analyzer Job Aid SIEMENS Healthineers CH Reagent Packs Assays for CH use 1, 2, or 3 reagents and most CH reagent packs contain 2 wells, which have separate onboard stability assigned by the system. A B Depending on the assay, CH reagents may be packaged in: MEMINS A. Single packs Trig Crea 2 P2 Crea 2 Pl Crea 2 B. Paired packs C. Kitted packs – depending on the assay, may include additional --- materials (for example Pretreatment for the A1c_E assay) Refer to the Instructions for Use (IFU) for the following reagent handling instructions: • Preparation – some reagents must be prepared prior to loading C SIEMENS Healthineers Atellicon CH A1c E Storage AIC E PRE • Attilicin CH 35.65 mL Alc E P2 MalDen CH Alc E P1 • Stability -- CE 8 There are 4 CH supplies that are packaged in reagent packs: WBA, RPC1, RPC2, and RPC4. These supplies are displayed on the Supply Needs screen. NOTE: The CH Assay Chart provides a list of assay details. The Assay Chart and the IFU’s can be found in the Document Library. 1 NOTE: Do not combine the contents of an unloaded reagent pack to a new reagent pack. Mixing reagent from Template Effective Date: 10 Aug 2021 | HILS 2223 the system to a new reagent pack can lead to erroneous results. Effective Date: 20-MAR-2023 | HOOD05162003340980 Unrestricted © Siemens Healthineers, 2023 Reagent Handling on the Atellica® CI Analyzer Job Aid SIEMENS Healthineers IM Reagent Packs A The IM assays use 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 3 assays B The IM reagent compartments are designed to hold: A. 20 primary reagent packs 2020-12-04 003693 B. 20 ancillary reagent packs LoTwin## 08923390 10996316 Fev.A 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. 5 A NOTE: The IM Assay Chart provides a list of assay details. This document can be found in 3 the Document Library. 2 Effective Date: 20-MAR-2023 | HOOD05162003340980 Unrestricted © Siemens Healthineers, 2023 Reagent Handling on the Atellica® CI Analyzer Job Aid SIEMENS Healthineers IM Reagent Packs A Depending on the assay, IM reagents may be packaged in: SIEMENS Healthineers A. Single packs Atellico IM For USA RxOnly For in vitro diagnostic use in the quantitative Dig determination of digoxin in human serum using the Atelica " IM Analyzer. B. Kitted packs – depending on the assay, may include ancillary For Professional Use. Contains: Life Reagent 2 5 not: Soid Prese 12 5 ml. reagent/calibrators/QC material, in addition to primary reagent F/50 ... ReadyPack" Siemens Heréticas Duigsorties inc. • For kitted packs, primary and ancillary reagents should be loaded and unloaded together. If a primary reagent is automatically unloaded, the operator may need to manually unload the corresponding ancillary reagent Refer to IFU for the following reagent handling instructions: B Atetilca" IM Preparation SIEMENS VitD • Healthineers Medico IM! Storage VitD SeedyPack • 20.0 ml • Stability VitD CAL VItD CAL Ready Pack ft NOTE: There are select assays that require lot locked ancillary reagents which are not included in the kit. Refer to the IFU. NOTE: Do not combine the contents of an unloaded reagent pack to a new reagent pack. Mixing reagent from the system to a new reagent pack can lead to erroneous results. 3 Effective Date: 20-MAR-2023 | HOOD05162003340980 Unrestricted © Siemens Healthineers, 2023 Reagent Handling on the Atellica® CI Analyzer Job Aid SIEMENS Healthineers Handling IM Reagent Packs NOTE: During off-system storage, solid phase particles settle as a pellet at the bottom of the primary reagent pack. If shutting down the Atellica CI Analyzer reagent compartment refrigeration for longer than 4 hours or in case of a power outage for longer than 5 minutes, remove and store all reagent packs: .......... 1. Cover the pierced film area of the reagent pack with self-sealing - laboratory film 2. Store any off-system reagent packs at 2-8 ◦ C 3. Before loading primary reagent packs onto the system, manually mix the packs to re-suspend the particles homogeneously 4. Return the reagent packs to the system when the reagent compartment temperature is 2-8 ◦ C 5. Verify reagent performance based on acceptable QC results or NOTE: If the reagent compartment is out of temperature range for greater than 60 laboratory criteria minutes, the system will flag results using those reagents as Reagent Compartment Temperature. If the system power was off: NOTE: When the IM primary reagent door is open longer than 5 minutes, the packs • For > 5 minutes, unload, manually mix, and reload all IM onboard will be indicated as mixing required. reagents • For > 4 hours, discard any reagents left in the reagent compartments 4 Effective Date: 20-MAR-2023 | HOOD05162003340980 Unrestricted © Siemens Healthineers, 2023 SIEMENS Healthineers Please note this 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 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. © Siemens Healthcare GmbH 2023 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens-healthineers.com 5 Effective Date: 20-MAR-2023 | HOOD05162003340980 Unrestricted © Siemens Healthineers, 2023