HYDRASYS PROGRAMMER 2 nd GENERATION Ref. 1239 INSTRUCTION SHEET IVD 2005/03
CONTENTS 1. FOREWORD...3 2. PRINCIPLE...4 3. INSTALLATION...4 3.1. TECHNICAL SPECIFICATIONS...4 3.2. CHECKING THE CONTENTS...4 4. USE...5 5. INTERFERENCES AND LIMITS OF USE...7 6. REGULATORY INFORMATION...7 7. INDEX...8-2/8- INSTRUCTION SHEET SEBIA - English
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
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
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
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
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 : 2000- "Quality Management Systems - Requirements", - EN ISO 13485: 2001- "Quality systems Medical devices Particular requirements of EN ISO 9001 ". With regard to European harmonized standards for EC marking (97/79/CE): - EN 591: 2001- "Instructions for use for in vitro diagnostic instruments for professional use", - EN 980: 2004- "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
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
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