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Microflow-S pocket Doppler   

 

 

 

User’s Documentation 

 

 

 

 

20 174 C 

 

 

 

Page 6/12 

 

4.5  Maintenance and service 

 

In case of breakdown of the 

MICROFLOW S

, please contact your Atys dealer. 

 

The 

MICROFLOW S

 performs properly only when operated and maintained as specified in this 

manual. 
It is the responsibility of the operator to use the MICROFLOW S in accordance with the user’s 
documentation, the warnings and the labels. 

 

 

If the 

MICROFLOW S

 is found defective, it should not be used. The MICROFLOW S should not be 

used if any parts are missing or are damaged. Parts that are visibly broken, worn out, warped or 
contaminated must be replaced. 

 

No components should be replaced with parts from any other manufacturer. If the customer 
suspects a part may be defective, it is the customer’s responsibility to contact Atys or Atys 
representative. The 

MICROFLOW S

 should only be repaired by technicians authorized by Atys. 

 

No modification of this equipment is allowed 

4.6  Ultrasound field 

 

Contraindication

: to be used by trained people, not use on ophthalmic, fetal application and fetal 

monitoring. 

 

The operator should limit the length of the Doppler tests to the time required for diagnostic purpose 
to minimize his/her exposure to ultrasound and as well the patient’s. 

4.7  Environmental protection 

 

Do not dispose the 

MICROFLOW S

 and its accessories in rubbish bins. They can be partially 

recovered and re-used. 

4.8  Electromagnetic compatibility 

 

Use of this equipment adjacent to or stacked with other equipment should be avoided because it 
could result in improper operation. If such use is necessary, this equipment and the other 
equipment should be observed to verify that they are operating normally.

 

 

Use of accessories, transducers and cables other than those specified or provided by the 
manufacturer of this equipment could result in increased electromagnetic emissions or decreased 
electromagnetic immunity of this equipment and result in improper operation.

 

 

The device shall not be used in home environment 

NOTE

 The emissions characteristics of this equipment make it suitable for use in industrial areas 

and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 
class B is normally required) this equipment might not offer adequate protection to radio-frequency 
communication services. The user might need to take mitigation measures, such as relocating or 
re-orienting the equipment.

 

 

Portable RF communications equipment (including peripherals such as antenna cables and 
external antennas) should be used no closer than 30 cm (12 inches) to any part of the 

Microflow-

S

, including cables specified by the manufacturer. Otherwise, degradation of the performance of 

this equipment could result.

 

 

The 

Microflow-S

 emits electromagnetic perturbations in ultrasound probe working frequencies, 

fundamental and third harmonics.  
The effects result from the high voltage and high frequency emission pulses. 
These perturbations do not allow to be compliant to the B class in every configuration 

 

Summary of Contents for Microflow-S

Page 1: ...Microflow S User s Documentation ...

Page 2: ...4 3 4 Intended user profile 4 3 5 Intended conditions of use 4 3 6 Expected service life 4 3 7 Contact duration on applied parts and accessible parts 4 3 8 Contraindication 4 3 9 Essential performance 5 4 CAUTION 5 4 1 Operator 5 4 2 Storage environment 5 4 3 Operating environment 5 4 4 Electrical safety 5 4 5 Maintenance and service 6 4 6 Ultrasound field 6 4 7 Environmental protection 6 4 8 Elec...

Page 3: ...EC60417 5134 IEC60417 5109 Applied part type BF ESD sensible Not for home use ISO7000 2498 ISO7000 2493 EN980 Serial number Catalogue reference number Manufacturer ISO 7000 2497 ISO7010 M002 Follow operating instructions With manufacturing year IEC60417 5009 Stand by Battery level Blink when low Sound volume adjust IEC60417 5134 Electrostatic sensitive device 1 2 Packaging ISO7000 626 ISO7000 2606...

Page 4: ...of tissue applied to or interacted with The detachable parts of the MICROFLOW S are applied on the patient s skin mainly of the limbs fingers toes and neck 3 4 Intended user profile The device must be used by or on the order of physician 3 5 Intended conditions of use The device shall be used in the specified environmental operating conditions 3 6 Expected service life hour per day 200 days year d...

Page 5: ...please contact your Atys dealer Do not use the MICROFLOW S if the packing of the device or of the probe is damaged The MICROFLOW S must be stored and moved in its box The complementary protective packing must be used in the case of a dispatch 4 3 Operating environment Climatic environment operating 15 25 C 10 80 Hr 700 1060 Hpa Do not use the device outside the specified environment To prevent fir...

Page 6: ...gnetic compatibility Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to verify that they are operating normally Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment coul...

Page 7: ...0601 1 6 5 6 Risk management The risk management is processed in compliance with ISO14971 5 7 Electromagnetic compatibility The Microflow S has been designed to work normally in conditions specified by the international standard IEC60601 1 2 2014 Information 1 Refer to the essential performance on this document Information relative to the A class limitation The MICROFLOW S emits electro magnetic p...

Page 8: ...Electromagnetic environment guidance Radiated RF IEC 61000 4 3 3 V m 80 MHz to 800 MHz 3 V m 800 MHz to 2 5 GHz 3 V m 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the Microflow S including cables than the recommended separation distance of 30cm or 12 inches Note 1 80 MHz to 2 7GHz the higher frequency range applies Note2 These guidelines may not app...

Page 9: ...e red LEDs indicate flow towards the transducer and three blue LEDs flow away from it The number of lightning LEDs is related to the flow intensity Since the device is bi directional the red and blue LEDs might light simultaneously This would indicate that an artery and a vein have been located at the same time The seven LEDs light up during 1 second when the device is switched on The probe is use...

Page 10: ... the probe must be performed There must not be any cracks or upheaval 7 4 BATTERY REPLACEMENT The battery should be replaced as soon as the yellow LED flashes Respect the battery type 9 V alkaline 6LR61 or PP3 Be careful about the polarity when replacing the battery 8 Service 8 1 Microflow S spare parts Order number designation Order number designation 04 739 Loud speaker 11 830 Microflow S keyboa...

Page 11: ...l work Switch off the unit 8 5 Probe connector wiring 9 Document revision history Reference 20 174 C MICROFLOW S User s documentation March 2017 Atys 17 Parc d Arbora F69510 SOUCIEU EN JARREST France Tel 33 4 78 05 69 69 Fax 33 4 78 05 69 60 Change R date Description 04 272 A March 16 2012 Initial release 05 371 B January 2017 Phase 401 revision 05 518 C March 2017 Accessories reference update Iss...

Page 12: ...es associées associés Classification per Annex IX Class IIa Classification Annexe IX Conformity Route Annex II section 3 Annexe Annexe II point 3 We herewith declare that the above mentioned product meets the provisions of the Council Directive 93 42 EEC for the Medical devices All supporting documentation is retained under the premises of Atys 69510 Soucieu en Jarrest FRANCE Nous certifions que l...

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