HYDRASYS PROGRAMMER. 2 nd GENERATION. Ref INSTRUCTION SHEET IVD 2005/03

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1 HYDRASYS PROGRAMMER 2 nd GENERATION Ref INSTRUCTION SHEET IVD 2005/03

2 CONTENTS 1. FOREWORD PRINCIPLE INSTALLATION TECHNICAL SPECIFICATIONS CHECKING THE CONTENTS USE INTERFERENCES AND LIMITS OF USE REGULATORY INFORMATION INDEX...8-2/8- INSTRUCTION SHEET SEBIA - English

INTERFERENCES AND LIMITS OF USE...7 6. REGULATORY INFORMATION.

3 1. FOREWORD In order to ensure the safety of both users and equipment, and in order to provide maximum performance at all times, users must become acquainted with the warnings given in this instruction sheet. Responsibilities of SEBIA: SEBIA may only be deemed responsible for consequences on the device s safety, reliability and specifications if this one is operated in accordance with the instructions herein. The specifications of the HYDRASYS PROGRAMMER are as described in this document. SEBIA reserves the right to alter these specifications without prior notice. -3/8- INSTRUCTION SHEET SEBIA - English

Responsibilities of SEBIA: SEBIA may only be deemed responsible for consequences on the device s safety, reliability and specifications if this one is

4 2. PRINCIPLE HYDRASYS PROGRAMMER is a memory card reader to update the software of HYDRASYS and HYDRASYS FOCUSING 2 nd GENERATION, SEBIA. 3. INSTALLATION 3.1. TECHNICAL SPECIFICATIONS Reading Dimensions Weight : Memory card SEBIA : L. 7 cm x H. 7 cm x D. 2,4 cm : 92 g 3.2. CHECKING THE CONTENTS Check that all the items listed below are present and intact: - 1 update unit, - 1 instruction sheet. TECHNICAL SUPPORT: Contact the SEBIA Technical Department if your device is defective. -4/8- INSTRUCTION SHEET SEBIA - English

2,4 cm : 92 g 3.2. CHECKING THE CONTENTS Check that all the items listed below are present and intact: - 1 update unit, - 1 instruction sheet.

5 4. USE Switch off the instrument. Connect the memory card reader without the memory card at the back on the 9 pin connector. Switch on the instrument and wait for the complete startup. Press key 2 to select SERVICE PROGRAM from the main menu. Type in the access code: 4644 (the code is not displayed on the screen). Press the key to confirm the access code. Press key 3 to select MEMORY and then key 2 to select the «FLASH PROG.. When the system asks «RELOAD THE SOFTWARE?», select «1 - CONTINUE». The display indicates «--- SHUTTING DOWN ---» and emits at the same time, a series of successive beeps every three seconds. Insert the chip side of the card into the memory card reader slot with the white side (back of the card) visible. After approximately 80 seconds, the beeps stop. -5/8- INSTRUCTION SHEET SEBIA - English

Press key 3 to select MEMORY and then key 2 to select the «FLASH PROG.. When the system asks «RELOAD THE SOFTWARE?», select «1 - CONTINUE».

Wait until the end of the upload process and the new startup of the instrument. The upload process takes approximately 6 minutes. Switch off the instrument. Remove the memory card.

6 Wait until the end of the upload process and the new startup of the instrument. The upload process takes approximately 6 minutes. Switch off the instrument. Remove the memory card. Disconnect the update unit. Switch on the instrument and wait for the complete startup. On the keypad: Press key 2 to select SERVICE PROGRAM from the main menu. Type in the access code: 4644 (the code is not displayed on the screen). Press the key to confirm the access code. Press key 4 to select SELECTION LANGUAGE followed by the key next to the language you wish to use. -6/8- INSTRUCTION SHEET SEBIA - English

On the keypad: Press key 2 to select SERVICE PROGRAM from the main menu. Type in the access code: 4644 (the code is not displayed on the screen).

7 5. INTERFERENCES AND LIMITS OF USE See the SEBIA HYDRAGEL kits instruction sheets. 6. REGULATORY INFORMATION SEBIA satisfies the following requirements: With regard to European directives: -98/79/CE on in vitro diagnostic medical devices, With regard to quality management standards: - EN ISO 9001 : "Quality Management Systems - Requirements", - EN ISO 13485: "Quality systems Medical devices Particular requirements of EN ISO 9001 ". With regard to European harmonized standards for EC marking (97/79/CE): - EN 591: "Instructions for use for in vitro diagnostic instruments for professional use", - EN 980: "Graphical symbols for use in the labelling of medical devices", - EN ISO 14971:2001- "Medical devices - Application of risk management to medical devices". - -7/8- INSTRUCTION SHEET SEBIA - English

EN ISO 9001 : 2000- "Quality Management Systems - Requirements", - EN ISO 13485: 2001- "Quality systems Medical devices Particular requirements of EN ISO 9001 ".

8 7. INDEX C CHECKING THE CONTENTS... 4 F FOREWORD... 3 I INSTALLATION... 4 INTERFERENCES AND LIMITS OF USE... 7 P PRINCIPLE...4 R REGULATORY INFORMATION...7 T TECHNICAL SPECIFICATIONS...4 U USE...5-8/8- INSTRUCTION SHEET SEBIA - English

9 Benelux s.a. / n.v. Rue de la Fusée, 62 Raketstraat, Bruxelles / Brussel BELGIQUE / BELGIË GmbH Michael Henkel Straße Fulda DEUTSCHLAND Hispania S.A. C/Sicilia, Barcelona ESPAÑA Parc Technologique Léonard de Vinci Rue Léonard de Vinci CP 8010 Lisses EVRY CEDEX - FRANCE ISO Italia s.r.l. Via Antonio Meucci, 15/a Località Ponte a Ema Bagno a Ripoli, Firenze ITALIA Inc Corporate Drive Norcross, Georgia U.S.A.

Introduction 1 The system 1 The meter 2 The display 3 The mode 3 The measurement 4 Coding the meter 4 How to obtain a drop of blood 6 Application of

Introduction 1 The system 1 The meter 2 The display 3 The mode 3 The measurement 4 Coding the meter 4 How to obtain a drop of blood 6 Application of the blood 7 Procedure to test glucose 7 Procedure to