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 +49 8142 448 460 

[email protected] 
www.medingmbh.com 

 

 
 

 

 

 

 

 

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medin Medical Innovations GmbH 
Adam-Geisler-Str. 1 
D-82140 Olching

 

 

OP_medinSINDI EN 
Rev 14      Stand 30.10.2017 

 
 

Immunity test 

IEC 60601 test level 

Compliance level 

Electromagnetic environment - guidance 

 

 

 

Portable  and  mobile  RF  communications 
equipment should be used no closer to any 
part  of  the  medinSINDI

®

,  including  cables, 

than 

the 

recommended 

separation 

distance  calculated  from  the  equation 
applicable  to  the  frequency  of  the 
transmitter.  

Recommended separation distance:  

Conducted  RF 
IEC 61000-4-6 

3 V

rms

 

150 kHz 

to 

80 MHz 

3 V

rms

 

𝑑 = 1.2√𝑃

 

Radiated  RF  IEC 
61000-4-3 

3 V/m 

80 MHz to 2.5 GHz 

3 V/m 

𝑑 = 1.2√𝑃

 80 MHz to 800 MHz 

 

𝑑 = 2.3√𝑃

 800 MHz to 2.5 GHz 

 

 

 

Where  P  is  the  maximum  output  power 
rating  of  the  transmitter  in  watts  (W) 
according  to  the  transmitter  manufacturer 
and  d  is  the  recommended  separation 
distance in metres (m).  

Field  strengths  from  fixed  RF  transmitters, 
as  determined  by  an  electromagnetic  site 
survey

a

,  should  be  less  than  the 

compliance level in each frequency range.

b

 

Interference  may  occur  in  the  vicinity  of 
equipment  marked  with  the  following 
symbol:  

 

Note 1:  

At 80 MHz and 800 MHz, the higher frequency range applies. 

Note 2:  

These  guidelines  may  not  apply  in  all  situations.  Electromagnetic  propagation  is  affected  by 
absorption and reflection from structures, objects and people.  

Field  strengths  from  fixed  transmitters,  such  as  base  stations  for  radio  (cellular/cordless) 
telephones  and  land  mobile  radios,  amateur  radio,  AM  and  FM  radio  broadcast  and  TV 
broadcast  cannot  be  predicted  theoretically  with  accuracy.  To  assess  the  electromagnetic 
environment  due  to  fixed  RF  transmitters,  an  electromagnetic  site  survey  is  to  be 
recommended. If the measured field strength in the location in which the  medinSINDI

®

 is used 

exceeds the applicable RF compliance level above, the medinSINDI

®

 must be observed to verify 

normal  operation.  If  abnormal  performance  is  observed,  additional  measures  may  be 
necessary, such as re-orienting or relocating the medinSINDI

®

.  

Over the frequency range 150 kHz - 80 MHz field strengths should be less than 3 V/m.  

 
 
 
 
 

Summary of Contents for medinSINDI 1080

Page 1: ...Operating cleaning and maintenance instructions medinSINDI Universal Gas Supply Unit with Pressure Monitor...

Page 2: ...cts at the time of initial purchase If the product should have any defects during the period of the warranty at the time of the initial purchase based on material or workmanship the manufacturer or hi...

Page 3: ...ed by the manufacturer i repairs or attempts at repair made by persons not authorised by the manufacturer j adaptations or changes without prior written agreement of the manufacturer k product upgrade...

Page 4: ...g term storage 12 3 4 2 Connection 12 3 4 3 Operating and Idle Times 12 3 4 4 Interruption of the External Power Supply 12 3 4 5 Background Illumination Display 12 3 4 6 Power supply connection 12 3 5...

Page 5: ...ing process 12 Figure 3 Connection to Medijet 14 Figure 4 medinSINDI front 15 Figure 5 medinSINDI Monitor 16 Figure 6 Oxygen concentration trend 18 Figure 7 Special function buttons 19 Figure 8 Servic...

Page 6: ...inSINDI may not come into contact with flammable anaesthesia gases or other flammable materials while in use Electromagnetic Compatibility It is confirmed that the device meets the EMC guidelines 89 3...

Page 7: ...s the mixer automatically reduces the pressure of the other gas as long as the difference between the two gases is not greater than 100 kPa 1 bar The flowmeter with a needle valve can be adjusted from...

Page 8: ...atus display and alarm Overpressure alarm in 3 seconds if the patient pressure exceeds 10 cm H2O Microprocessor controlled input of programmes on FLASH technical upgrade 2 2 Controls and Displays Flow...

Page 9: ...on condensing Storage 0 95 non condensing Environmental conditions for the medinSINDI during operation Ambient pressure 700hPa to 1100hPa Altitude 2000m above sea level Environmental conditions of the...

Page 10: ...sional service personnel and only in accordance with the instructions in the Maintenance Manual observing warnings in the manual and in these instructions for use see chapter 6 3 The medinSINDI and it...

Page 11: ...INDI monitors the pressure of both gases to ensure this correct gas mixture medinSINDI requires both gases simultaneously for the connection otherwise an acoustic alarm will immediately sound Loss of...

Page 12: ...t times With external power supply Continuous operation possible ICU Important Note Battery When the battery is nearly depleted an alarm sounds once per minute for 1 second The charging process is sho...

Page 13: ...rning The plug of the power supply unit of the medinSINDI must also always be freely accessible even when set up in order to allow the medinSINDI to be quickly disconnected from the mains in the event...

Page 14: ...generator Connect temperature probe and power cable F Connect the nCPAP pressure line on the Medijet and guide back to the medinSINDI It will be connected there at the PATIENT connection in order to...

Page 15: ...ch the patient and the device This applies above all to the power supply the alarm or RS232 Interface and the accessible metal parts of the pneumatic unit gas connections The adapter should not be use...

Page 16: ...e of a maximum of 10 cmH2O can be measured and displayed in pressure curve A and at pressure value B Starting with software version 1 017 values up to 10 cmH2O are displayed in pressure curve A and a...

Page 17: ...atically turns off the blinking alarm symbol LOW CPAP in the middle of the monitor If medinSINDI measures an nCPAP pressure greater than 1 5 cmH2O after the pressure line has been attached medinSINDI...

Page 18: ...pressure measurement is necessary to determine the respiratory rate The pressure difference must be approx 1 cmH2O during inhalation and exhalation The rate is determined calculated and displayed in e...

Page 19: ...ignal is now turned off in the event of an alarm In the event of an alarm only a visual signal appears on the monitor and incorrect data are indicated by blinking To reactivate the acoustic alarm the...

Page 20: ...medinSINDI will no longer work correctly and the patient will be at risk 4 4 3 1 Oxygen Calibration Connect a calibrated oxygen measuring device to the patient gas outlet Open the flow of the medinSIN...

Page 21: ...must be checked using a manometer connected via a T piece Figure 11 Manometer for pressure calibration After the calibration is completed the service menu reappears Important Note Pressure Calibration...

Page 22: ...al Data The current software version can be found in this file This is used to identify the CPU system and the special functions for the measuring transducer and the O2 cell The CPU works with Flash M...

Page 23: ...een two different alarm centres the gas mixer and the CPU monitor 5 1 Gas Mixer Pneumatic acoustic alarm is triggered independently of the electronics if one of the two supply gases is missing air O2...

Page 24: ...ion and confirm with Confirm FiO2 Gas supply Alarm 30 sec Loud acoustic alarm mechanical one gas is missing Check gas supply Air connected Oxygen connected Difference between oxygen air 1 bar Differen...

Page 25: ...rs at the latest The replacement battery must be a rechargeable battery of the same type can be ordered from medin REF 51095 Warning The internal battery may only be replaced by the battery types list...

Page 26: ...d an oxygen concentration of 98 is shown on the display Important Note Test for Oxygen Calibration Before each use of medinSINDI on a new patient it is recommended that a test be conducted to determin...

Page 27: ...ir Oxygen Flowmeter Flow setting Only for sindi FiO2 setting Alarm unit Sound generator Difference pressure regulator Difference pressure regulator Flow outlet Pneumatic diagram Medin Blender 1085 Med...

Page 28: ...wing symbols are used on medinSINDI or in the accompanying documentation Symbol Source Compliance Meaning Symbol Source Compliance Meaning 60601 1 ISO 7010 M002 Follow instructions for use EN 980 2008...

Page 29: ...rm level for maximum CPAP downwards Lower CPAP alarm level for minimum CPAP upwards Confirm nCPAP setting Confirm FiO2 settings Flow Inspiratory oxygen concentration Table 4 medinSINDI Display Symbols...

Page 30: ...distance required must be calculated in accordance with chapter 0 on the basis of the transmission frequency 9 1 Electromagnetic transmission Guidance and manufacturer s declaration electromagnetic em...

Page 31: ...ower supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surges IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV diffe...

Page 32: ...tic site surveya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz th...

Page 33: ...as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance acc to transmission frequency m 150 kHz to 80...

Page 34: ...Quant MC Envitec Flow analyser PF 302 LOW IMT Flow analyser PF 300 IMT Mass flowmeter Model 4143 TSI Manometer 0 25 cm WS Suchy Test of oxygen calibration 21 3 ok nok 40 3 ok nok 60 3 ok nok 100 3 ok...

Page 35: ...with the CPU 2006 First medin medinSINDI models for testing 2006 Laboratory measurements and EMC laboratory testing 2007 Start of production 2007 Upgrading of the software for better patient monitori...

Page 36: ...49 8142 448 460 info medingmbh com www medingmbh com 36 von 36 medin Medical Innovations GmbH Adam Geisler Str 1 D 82140 Olching OP_medinSINDI EN Rev 14 Stand 30 10 2017...

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