biolog id SMART STORAGE AGITATOR 30 User Manual Download Page 21

 

User Manual Smart Storage Agitator 30

 

Version

 : 1.0 

 

Validation date of the manual: 01/08/2021 

21 of 29 

 

(IEC61000-3-2) 
Voltage variations, voltage 
fluctuations and flicker 
(IEC61000-3-3) 

Compliant 

 
Magnetic and electromagnetic immunity  
The  SST-A30  is  intended  to  be  used  in  the  magnetic  and  electromagnetic  environment 
described in the table below. The user and the installer must guarantee the compliance of the 
electromagnetic environment. 

Immunity test

 

Test level according to 

IEC60601

 

Compliance level

 

Electromagnetic 

environment/comments

 

Electrostatic 
discharge (ESD)  
(IEC61000-4-2)  

± 8 kV contact 
discharge  
± 2 kV; ± 4 kV; ± 8 kV; 
± 15 kV air discharge  

± 8 kV contact 
discharge  
± 15 kV air discharge  

Professional healthcare 
facility environment.  

Fast transient 
bursts  
(IEC61000-4-4)  

± 2 kV for power 
supply lines  

± 2 kV for power supply 
lines  
± 1 kV for signal ports  

Professional healthcare 
facility environment.  

Surges  
(IEC61000-4-5)  

± 1 kV in Differential 
mode  
± 2 kV in common 
mode  

± 1 kV in Differential 
mode  
± 2 kV in common 
mode  

Professional healthcare 
facility environment.  

Power-frequency 
magnetic field  
(IEC61000-4-8)  

30 A/m  

30 A/m  

Professional healthcare 
facility environment.  

Voltage dips, short 
interruptions, and 
voltage variations  
(IEC61000-4-11)  

0% UT for 0.5 cycles  
At 0°, 45°, 90°, 135°, 
180°, 225°, 270° and 
315°  
0% UT for 1 cycle  
70% UT  
for 25 cycles at 50 Hz  
For 30 cycles at 60 Hz  
Single-phase: at 0°  

0% UT for 0.5 cycles  
At 0°, 45°, 90°, 135°, 
180°, 225°, 270° and 
315°  
0% UT for 1 cycle  
70% UT  
for 25 cycles at 50 Hz  
For 30 cycles at 60 Hz  
Single-phase: at 0°  

Professional healthcare 
facility environment.  

Voltage 
interruptions  
(IEC61000-4-11)  

0 % UT;  
for 250 cycles at 50 Hz  
for 300 cycles at 60 Hz  

0 % UT;  
for 250 cycles at 50 Hz  
for 300 cycles at 60 Hz  

Professional healthcare 
facility environment.  

 

 

Summary of Contents for SMART STORAGE AGITATOR 30

Page 1: ...NUAL SMART STORAGE AGITATOR 30 SST A30 Headquarters 1 rue du Commandant Robert Malrait ZA des Granges BP 30303 27303 Bernay cedex France Phone 33 0 2 32 47 83 40 Fax 33 0 2 32 47 83 50 Web www biolog...

Page 2: ...ower 8 2 3 2 Drawer 9 2 3 3 Satellite 9 2 3 4 Temperature sensor 10 2 3 5 Agitator sensor 10 2 4 Hardware and software compatibility 10 2 4 1 Agitator 10 2 4 2 Climate chamber 10 2 4 3 RFID tag 11 2 4...

Page 3: ...tion date of the manual 01 08 2021 3 of 29 5 Cleaning Instructions 25 6 First Level Maintenance 26 7 Warranty 27 8 Transport 27 9 Manufacturer Responsibility 27 10 Lifetime 28 11 Disposal and recyclin...

Page 4: ...ined for the life of your equipment 1 2 Manual Recipient This manual is for all users groups in SST A30 throughout its cycle of usage All topics and important areas for different groups are treated 1...

Page 5: ...e SST A30 is a class I medical device used as an accessory to the Helmer PF48 Platelet Agitator The SST A30 is a Radio Frequency Identification RFID product applied to the traceability of Platelet Con...

Page 6: ...ges the climatic aspects temperature and hygrometry of conservation of labile blood products SST A30 does not alter the performance of the platelet agitator nor the performance of the incubator in whi...

Page 7: ...8 2021 7 of 29 3 months 20 C to 45 C 1 month 20 C to 60 C Button cell CR2032 Recommended 10 C to 25 C not to exceed 30 C Operating Humidity 40 RH to 95 RH Maximum storage humidity 40 RH to 95 RH FYI C...

Page 8: ...components of the SST A30 as well as their function Fig 3 SST A30 set 2 3 1 Calculator and Power Fig 4 Calculator and its power supply set The calculator in the SST A30 system is responsible for manag...

Page 9: ...29 2 3 2 Drawer The drawer is the component for storing the PC bags Fig 5 Drawer 2 3 3 Satellite A RFID satellite placed between two drawers allows the localization of PC bags The satellite is a subse...

Page 10: ...s to measure the temperature of an area Fig 7 Temperature sensor Only the temperature of the climatic chamber incubator is the reference SST A30 has no claimed performance regarding temperature The SS...

Page 11: ...ntered on the bag Fig 8 Platelet concentrate bag and RFID tag Fig 9 Tag positioning You must place your RFID tag on the center of your bag so that the RFID tag cannot be within 2cm of the edges of the...

Page 12: ...a third party software and communicate via its web service to share exchange PC traceability data standard communication protocol The third party software can then request the SST A30 to write data to...

Page 13: ...2 Place the PC bag on the drawer Note In diagnostic mode verification of the operation of RFID and LEDs the front of the satellite flashes PC bags can be placed in any direction in the width or length...

Page 14: ...potentially discharged Refer to chapter First Level Maintenance of this manual GREEN LED ON steady RED LED OFF Normal and functional operation mode GREEN LED ON blinking RED LED OFF Maintenance and fu...

Page 15: ...re details above this table ORANGE LED ON blinking A drawer is left open more than 4 minutes Close the drawer RED LED ON steady Note There is potentially no traceability at the location where the indi...

Page 16: ...tellite 2 is lit in orange drawer 3 The LED of satellite 2 is lit in orange The LED of satellite 3 is lit in orange drawer 4 The LED of satellite 3 is lit in orange The LED of satellite 4 is lit in or...

Page 17: ...ed in the Platelet agitator so that it cannot be disassembled without the use of a tool as part of a maintenance operation Never allow water or other liquids to enter the equipment to avoid the risk o...

Page 18: ...stallation site on the nameplate before connecting the installation Electric Follow the wiring diagrams of the machine Electric Connect inevitably the device to a socket protected by a protective cond...

Page 19: ...ility The SST A30 complies with applicable electromagnetic compatibility standards however the user will ensure that any electromagnetic interference does not create an additional hazard such as radio...

Page 20: ...to be used in an electromagnetic environment in which radiated RF disturbances are controlled The user or installer of the medical device can help prevent any electromagnetic interference by maintaini...

Page 21: ...power supply lines 2 kV for power supply lines 1 kV for signal ports Professional healthcare facility environment Surges IEC61000 4 5 1 kV in Differential mode 2 kV in common mode 1 kV in Differentia...

Page 22: ...rsely affected Radiated RF electromagnetic fields IEC61000 4 3 3 V m 80 MHz to 2 7 GHz 80 MA at 1 kHz 3 V m 80 MHz to 2 7 GHz 80 MA at 1 kHz Professional healthcare facility environment Proximity fiel...

Page 23: ...ouraged to try to correct the interference by one of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment...

Page 24: ...e collocated or operating in conjunction with any other antenna or transmitter Le pr sent appareil est conforme aux CNR d Industrie Canada applicables aux appareils radio exempts de licence L exploita...

Page 25: ...t spray to the area to be treated or to a nonwoven wipe 2 Distribute the product To clean and maintain the proper functioning of the SST A30 we advise you to follow the instructions below Before each...

Page 26: ...e mode and then restart the calculator 2 Contact Biolog id support The drawer satellite has ORANGE LED ON steady An error occurs while reading writing an RFID chip with no hardware failure identified...

Page 27: ...third party system Contact the administrator Contact the supplier of your device in case of malfunction Do not repair or modify the device without prior authorization from Biolog Id Any maintenance o...

Page 28: ...al regulations The individual components of the SST A30 must be sorted and processed according to the appropriate waste disposal channels The different components of the SST A30 being electrical and e...

Page 29: ...d to each supplier and provided by BIOLOG_ID BI represents Biolog Id Year 2 characters 00 to 99 16 represents 2016 Week 2 characters 01 to 52 45 represents week 45 Serial number 6 characters 000001 to...

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