Hitachi Phadia-250 Instruction Manual
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Hitachi Phadia-250 Instruction Manual

Hitachi Phadia-250 Instruction Manual

Roche diagnostics connector to cobas 8100 (pcm1)
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NN1-1203_R10
Instruction Manual
Roche Diagnostics
Phadia-250 Connector to cobas 8100 (PCM1)
ATU-PVT-PCM1
Before using this system, be sure to thoroughly read this
manual and make yourself familiar with this system.
After reading this manual, keep it in an easily accessible place
close to the system.
Original Instructions
The original version of this document is in English.
You can find the original and translated versions of this document
at:
dialog.roche.com.
Hitachi, Ltd.
© Hitachi, Ltd. 2018, 2022. All rights reserved.
NN1-1536 Rev.03.1

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  • Page 1 After reading this manual, keep it in an easily accessible place close to the system. Original Instructions The original version of this document is in English. You can find the original and translated versions of this document dialog.roche.com. Hitachi, Ltd. © Hitachi, Ltd. 2018, 2022. All rights reserved. NN1-1536 Rev.03.1...
  • Page 2 Deleted “Automation Solutions GmbH” from Roche company name. (Front cover) Changed the company names to “Roche Diagnostics” and “Hitachi Ltd”. Added barcode reader product label to “Important Safety Information (Warning Labels)”. Added“(EU)2015/863” to RoHS directive. Added IVD Regulation to “Norms and standards”.
  • Page 3 NN1-1536 Rev.03.1 ATU-PVT-PCM1 Instruction Manual Added the section “Incident Reporting”. (“Before Reading this Manual”) Added the table “Storage environment specifications. Added the table “Each unit Sound Pressure Level”. Added the section “Electromagnetic Compatibility”. (Chapter 1-3) Updated “Unit Plate” table and symbol table (Chapter 1-4) Added description regarding cleaning frequency.

  • Page 4: Table Of Contents

    Intended Purpose Safety Precautions Usage Conditions Primary Power switch and System Power Switch Clean-up Procedures Chapter 2 Operation Instructions Specifications Part names and functions Instructions Alarm conditions and corrective actions Table of Contents Page - 1 of 1 - Hitachi, Ltd.

  • Page 5: Before Reading This Manual

    ■ Before Reading This Manual This manual is an instruction manual describing the proper and safe usage of the Phadia-250 Connector to cobas 8100 (PCM1) for Roche Diagnostics. This instruction is intended for persons who were trained to operate and maintain this In Vitro Diagnostic Device.

  • Page 6: Important Safety Information (Warning Labels)

    Injury to humans, not including death or serious injury, injury: and typically does not result in permanent disability or significant disfigurement or pain. Examples of minor or moderate injuries include cuts, scratches, and irritation. Before Reading this Manual Hitachi, Ltd. Page - 2 of 4 -...
  • Page 7 Turn OFF power switch when maintain the unit. These units have moving mechanical parts inside of the unit protection barrier. Be careful not to pinch hands or fingers to avoid injury. Before Reading this Manual Hitachi, Ltd. Page - 3 of 4 -...
  • Page 8 ATU-PVT-PCM1 Instruction Manual < Copyrights > This manual is a product of Hitachi, Ltd. for Roche Diagnostics. All rights are reserved. No parts of this manual may be reproduced in any form (print, photocopy, microfilm or another procedure) or processed using electric systems, copied or distributed without the written permission of the company.
  • Page 9 1-1 Intended Purpose .............. 2 1-2 Safety Precautions ............2 1-3 Usage Conditions .............. 5 1-4 Primary Power switch and System Power switch .... 8 1-5 Clean-up Procedures ............11 Chapter 1 Safety Precautions Hitachi, Ltd. Page - 1 of 11 -...

  • Page 10: Intended Purpose

    ATU-PVT-PCM1 Instruction Manual 1 -1 Intended Purpose Phadia-250 Connector to cobas 8100 (PCM1) is intended for automated transfer of patient samples and sample identification between cobas 8100 and IVD analyzers. The intended users of this device are trained laboratory technicians and trained field service engineers (professional use only).
  • Page 11 Your personal protective equipment should be appropriate to the degree and type of potential hazard, e.g. suitable lab gloves, eye protection, lab coat, and footwear. Chapter 1 Safety Precautions Hitachi, Ltd. Page - 3 of 11 -...
  • Page 12 Unusual activities may lead to system damage. To avoid it, follow the instructions.  Power off the Unit by turning off the Primary Power switch or unplug the cable from AC outlet socket. Chapter 1 Safety Precautions Hitachi, Ltd. Page - 4 of 11 -...

  • Page 13: Usage Conditions

     The Unit has a circuit breaker for over current protection at Power Supply Unit.  No measures are provided for the interruption of AC power supply. Measures for main AC power interruption must be provided by end user if necessary. Chapter 1 Safety Precautions Hitachi, Ltd. Page - 5 of 11 -...

  • Page 14: Sound Pressure Level

    If you continue to have difficulties, contact your local Roche service representative. Chapter 1 Safety Precautions Hitachi, Ltd. Page - 6 of 11 -...
  • Page 15 114 kg 800 mm 500 mm Note: Dimension (Height) includes Acrylic glass cover but not include status light. Dimension (Depth) does not include resin plate for Phadia-250 mechanical connection. ATU-PVT-PCM1 Figure 1 Front View Figure 2 Top View Chapter 1 Safety Precautions Hitachi, Ltd.

  • Page 16: Primary Power Switch And System Power Switch

    Unit. Mark Purpose Display Primary Power switch Primary Power Switch ON │ Switch OFF О System Power Switch System Power Switch ON Switch OFF ATU-PVT-PCM1 Figure 1 Chapter 1 Safety Precautions Hitachi, Ltd. Page - 8 of 11 -...
  • Page 17 <IVDD compliant name plate> identification (UDI)> YYYY.MM indicates manufacture year and month. YYYY.MM <CE marking plate attached with IVDD Unit plate> <New power rating plate attached with IVDR Unit plate> Chapter 1 Safety Precautions Hitachi, Ltd. Page - 9 of 11 -...
  • Page 18 Consult instructions for use the European Community Intertek ETL listed mark (01) Global Trade Item Number (GTIN) (11) Production date (YYMMDD) Caution (21) Serial number (240) Catalogue number Chapter 1 Safety Precautions Hitachi, Ltd. Page - 10 of 11 -...

  • Page 19: Clean-Up Procedures

    When cleaning metal parts with neutral detergent, wipe them afterwards with a cloth moistened with water. 4. Make sure that the spilled sample content is not carried over to the connected systems. Chapter 1 Safety Precautions Hitachi, Ltd. Page - 11 of 11 -...
  • Page 20 Operation Instructions Phadia-250 Connector to cobas 8100 (PCM1) ATU-PVT-PCM1 This chapter describes specification, names, functions and instructions for Phadia-250 Connector to cobas 8100 (PCM1), ATU-PVT-PCM1. 2-1 Specifications ..............2 2-2 Part names and functions ........... 6 2-3 Instructions ................. 8 2-4 Alarm conditions and corrective actions ......

  • Page 21: Specifications

    This unit receives SSH with a sample tube from cobas 8100 passing through Universal Connection Unit (UCU) and transfer to Phadia-250. After Phadia-250 sampling is finished, SSH with the sample tube is sent back to cobas 8100 passing through UCU.
  • Page 22 Barcode label size must be less than sample tube length minus 26 mm. e.g. When the sample tube length is 73 mm, barcode label size must be less than 47 Hitachi, Ltd. Chapter 2 Operation Instructions Page - 3 of 16 -...
  • Page 23 Prepare SSH for the number of sample tubes to use.   Do not use damaged or cracked SSH.  Make sure no particle is adhered to SSH.  Periodical SSH check is recommended. Hitachi, Ltd. Chapter 2 Operation Instructions Page - 4 of 16 - ATU-PVT-PCM1...
  • Page 24 Risk of sample spillage Sample content may spill when using open sample tubes.  Fluids filled in open sample tubes must be 15mm below the tube’s upper rim. Hitachi, Ltd. Chapter 2 Operation Instructions Page - 5 of 16 - ATU-PVT-PCM1...

  • Page 25: Part Names And Functions

    Stored SSH’s are on the process to eject UCU forcibly OFF Line button OFF LINE Off : The unit runs normal operation. On : Button lamp lit. The unit stops new SSH receiving. Hitachi, Ltd. Chapter 2 Operation Instructions Page - 6 of 16 - ATU-PVT-PCM1...
  • Page 26 Figure 1 Parts Name BCR 2 Elevator Pull-in Conveyor BCR 1 Separator 1 Supply Lane Send-out Conveyor Separator 2 Rotation 2 Rotation 1 Traverse Return Lane Figure 2 Hitachi, Ltd. Chapter 2 Operation Instructions Page - 7 of 16 - ATU-PVT-PCM1...

  • Page 27: Instructions

    Always hold the acrylic glass cover firmly with both hands and take off when it is necessary.  Always hold SSH with both hands when it is necessary to remove SSH from inside the unit. Hitachi, Ltd. Chapter 2 Operation Instructions Page - 8 of 16 -...
  • Page 28 4) Push SSH toward to traverse mechanism (Refer to figure 3. Red arrow No.4 direction) and remove SSH from conveyor at position A. Knob for elevator Figure 3 Up/Down Area D Area A Area B Area C Position A Figure 4 Hitachi, Ltd. Chapter 2 Operation Instructions Page - 9 of 16 - ATU-PVT-PCM1...
  • Page 29 Then p ress [Reset] button approx. 3 seconds. pull-in elevator conveyor) All SSH in the PCM1 once ejects to UCU then unit performs initialization and resumes operation from next SSH. Hitachi, Ltd. Chapter 2 Operation Instructions Page - 10 of 16 - ATU-PVT-PCM1...
  • Page 30 Then p ress [Reset] button approx. 3 seconds. Protection barrier locks automatically and resume operation. All SSH in the PCM1 once ejects to UCU then unit performs initialization and resumes operation from next SSH. Hitachi, Ltd. Chapter 2 Operation Instructions Page - 11 of 16 - ATU-PVT-PCM1...
  • Page 31 Alarm sound stops and error ID clear from display. Then p ress [Reset] button approx. 3 seconds. Protection barrier locks automatically and resume Test Run after initialization. Hitachi, Ltd. Chapter 2 Operation Instructions Page - 12 of 16 - ATU-PVT-PCM1...
  • Page 32 Then p ress [Reset] button approx. 3 seconds. All SSH in the PCM1 once ejects to UCU then unit performs initialization and resumes operation from next SSH. Hitachi, Ltd. Chapter 2 Operation Instructions Page - 13 of 16 - ATU-PVT-PCM1...
  • Page 33 SSH. Traverse IDM status shows Check Phadia-250 analyzer condition. “Aspiration failed in sample Male sure Phadia-250 sampling nozzle is in the (do not move sample)”. sample tube, resume Phadia-250 error condition first. After Phadia-250 is resumed error condition, p ress [Reset] button.
  • Page 34 ID clear from display. Then press [Reset] button approx. 3 seconds. All SSH in the PCM1 once ejects to UCU then unit performs initialization and resumes operation from next SSH. Hitachi, Ltd. Chapter 2 Operation Instructions Page - 15 of 16 - ATU-PVT-PCM1...
  • Page 35 Barcode reader has Press [Reset] button. abnormal condition. Alarm sound stops and error ID clear from display. 1101 Then p ress [Reset] button approx. 3 seconds. Unit performs initialization. Hitachi, Ltd. Chapter 2 Operation Instructions Page - 16 of 16 - ATU-PVT-PCM1...
  • Page 36 Caution April 6 , 2022 NN1-1536 Rev.03.1 ● To keep Units performance, we recommend to perform periodical maintenance and maintenance contract. Hitachi, Ltd. <Your Distributor> 2-16-1,Higashi-Ueno Taito-ku,Tokyo,110-0015,Japan https://dialog.roche.com...

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