Moller Medical Liposat power Скачать руководство пользователя страница 33

 

Liposat

®

 power

 

Electromagnetic compatibility 

 

 

Page 33 of 36 

Immunity test / 
standard  

IEC 60601 - 
testing level 

Compliance 
level 

Electromagnetic environment guidelines 

Conducted HF 
disturbances in 
accordance with 

IEC 61000-4-6 

3 Veff 
150 kHz to 
30 MHz 

3 Veff 

Portable and mobile radio transmitting 
devices, including the cables, should be used 

in proximity of the 

Liposat

®

 power

 within the 

recommended safety distance calculated 
according to the applicable transmission 
frequency equation. 

Recommended safety distance: 

𝑑 = 1,2√𝑃

  for 80 MHz to 800 MHz 

𝑑 = 2,3√𝑃

  for 800 MHz to 2,5 GHz 

with P as nominal transmitter power in Watt 
(W) according to transmitter manufacturer 
stipulations and d as recommended safety 
distance in meters (m). 

According to an on-site

a)

 examination, the field 

intensity of stationary radio transmitters ought 
to be lower than the compliance level

b)

Disturbances may occur in the environment of 
devices carrying the following symbol. 

 

 

6 Veff in ISM and 
amateur radio 
frequency bands 
between 150 kHz 
and 80 MHz 

6 Veff 

Radiated HF 
disturbance 

value acc. to 
IEC 61000-4-3 

3 V/m 
80 MHz to 
2,7 GHz  

3 V/m 
80 MHz to 
2,7 GHz  

Table 9 of 
IEC 60601-1-2 
Ed. 4 

Table 9 of 
IEC 60601-1-2 
Ed. 4 

Note: 

NOTE 1: The higher frequency range applies to 80 MHz and 800 MHz. 
NOTE 2: These guidelines may not be applicable to all cases. The diffusion of nominal electromagnetic 
factors is influenced by absorption and reflection of buildings, objects and people. 

a)

 

The field strength of stationary emitters, such as base stations for mobile phones and mobile terrestrial 

radio systems, amateur radio stations, AM and FM radio and television emitters, cannot be theoretically 
accurately predicted. To determine the electromagnetic environment in terms of the stationary emitters, a 
study of the site should be considered. If the measured field strength in the location in which the 

Liposat

®

 power

 is used exceeds the applicable RF compliance level above, the 

Liposat

®

 power

 should 

be observed to verify normal operation. If abnormal performance is observed, additional measures may be 

necessary, such as reorienting or relocating the 

Liposat

®

 power

b)

 Above the frequency range of 150 kHz to 80 MHz the field strength should be lower than 3 V/m. 

 

Recommended safety distances 

See chapter “

Electromagnetic immunity

 

“. 

Содержание Liposat power

Страница 1: ...Liposat power Instruction for use en...

Страница 2: ...IMPORTANT READ CAREFULLY BEFORE USE KEEP THESE INSTRUCTIONS FOR FUTURE CONSULTATION...

Страница 3: ...Manufacturer Page 3 of 36 Manufacturer M ller Medical GmbH Wasserkuppenstra e 29 31 36043 Fulda Germany Tel 49 0 661 94 19 5 0 Fax 49 0 661 94 19 5 850 http www moeller medical com E mail info moelle...

Страница 4: ...fety monitoring 11 Technical data 12 General safety instructions 13 Obligations to the operator 13 Explanation of the safety symbols that are used 15 One time use 17 Warnings 17 Precautions 17 Transpo...

Страница 5: ...personnel 24 Assistance with problems 25 Service station 27 Cleaning and care 28 Cleaning and disinfection 28 Maintenance 28 Disposal 29 Accessories and consumables 30 Electromagnetic compatibility 3...

Страница 6: ...e aqueous solutions for the production of tumescence local anesthesia as well as body owning subcutaneous tissue and its components in the body The tumescence pump Liposat Pro may only be used with th...

Страница 7: ...Liposat power Product description Page 7 of 36 Product overview...

Страница 8: ...e Up button or lowered with the Down button at intervals of 10 from 40 ml min to 300 ml min The maximum infiltration amount ml is adjusted with the soft key button Volume The infiltration volume can b...

Страница 9: ...on is shown on the display 1 Selected flow rate ml min 2 Selected infiltration volume ml 3 Infiltrated volume ml 4 Infiltrated volume ml as a bar chart 5 Infiltration time 6 Heating dish 1 active 7 He...

Страница 10: ...he other end of the Efferent tube to the distributor 3 way stopcock Always ensure that all hoses lie unencumbered and are not pinched or kinked Use the Reset Function to prime the tube set For this pu...

Страница 11: ...ay be interrupted at any time by pressing the Start Stop button 9 No settings will be changed by interrupting the infiltration However these settings can be changed at any time The device does not req...

Страница 12: ...I Applied part B Schlauchset f r Tumeszenzpumpe Liposat power REF Nr 00002251 General characteristics Permissible operating conditions Temperature Humidity 10 C to 40 C 30 to 75 relative humidity Perm...

Страница 13: ...on plate No liquids should get into the electrical parts Unplug the device plug before cleaning The plug connections to the Liposat power mains cable foot switch heating dishes should be plugged in or...

Страница 14: ...de of the Liposat power using the screws that are supplied The manufacturer can consider itself responsible for the safety reliability and usability of the device only if assembly expansions new setti...

Страница 15: ...e service personnel as well as to avoid damage to the product or functional disturbances Caution Information Typ B applied part ON power OFF power Start stop button Reset button for infiltrated volume...

Страница 16: ...o not resterilise Manufacturer Do not use if package is damaged Contains or presence of phthalates Stacking limit do not store more than 3 packs high Attention Under US Federal law this device may be...

Страница 17: ...healing and the age of the patient all affect the outcome and must be taken into consideration Loss of body materials blood lymph tissue fluid etc can occur through intra operative or post operative u...

Страница 18: ...g LxWxH 390 mm x 330 mm x 335 mm Weight approx 12 kg Transport and storage conditions Temperature 10 C to 50 C Humidity Less than 90 relative humidity A maximum of 3 cartons may be piled on one anothe...

Страница 19: ...ks for the device combination with the Vacusat power M ller Medical GmbH including fastening screws Additional equipment that is not part of the scope of delivery of the device Additional equipment at...

Страница 20: ...erating theatres except for in the proximity of active facilities of RF surgery devices or outside of the RF shielded room for magnetic resonance imaging first aid facilities The Liposat power is not...

Страница 21: ...avoided monitor the Liposat power and other devices to verify specified normal use When using as a tabletop device proceed in the following prescribed order Take the Liposat power tumescence pump out...

Страница 22: ...ead screw with M5x8 hexagon socket Hang the Liposat power tumescence pump on the upper hanging rail of the Vacusat power surgical suction device using the screwed in fastening hooks Connect the suppli...

Страница 23: ...he notice Door opened will appear in the display 3 Insert the adapter of the suction side Afferent tube of the pump see the illustration 4 Turn the pump rotor by hand counter clockwise The tube will b...

Страница 24: ...rature too hot Physiological alarm condition None Technical alarm condition Temperature sensor reports greater than 43 0 C for the package with the tumescence solution Alarm limit 43 0 C Alarm delay 1...

Страница 25: ...f when disconnecting or connecting the connectors If the problems cannot be solved by the solutions described here contact the service department of the manufacturer service moeller medical com or one...

Страница 26: ...ly inserted in the package for tumescence solution The package with tumescence solution is empty The pump is equipped with an additional safety function that prevents the burst of the tube system With...

Страница 27: ...ction procedure must rule out any possible risk of infection Consumables are accordingly to be disposed of according to hygiene guidelines Service note Never open the device while it is connected to t...

Страница 28: ...ptol During disinfection do always follow the instructions of the disinfectant manufacturer Ensure that the cleaning and disinfecting agents have evaporated before using the Liposat power in an applic...

Страница 29: ...device is subject to the European Directive 2012 19 EU on Waste Electric and Electronic Equipment WEEE2 The identification plate of the device bears the symbol of the crossed through garbage bin Retur...

Страница 30: ...ensions of the heating dishes with packaging L x W x H 540 mm x 300 mm x 300 mm Weight approx 4 8 kg Electrical foot switch 2 m cable with start stop function Order no 93003545 Electrical foot switch...

Страница 31: ...as of application see chapter Suitable operating environments Harmonic emissions acc to IEC 61000 3 2 Class A Voltage fluctuations flicker emissions acc to IEC 61000 3 3 Complies Electromagnetic immun...

Страница 32: ...ction even during an interrupted power supply Magnetic field in power supply frequency 50 60 Hz IEC 61000 4 8 30 A m 30 A m Magnetic fields of the supply frequency should conform with the typical valu...

Страница 33: ...bance value acc to IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 3 V m 80 MHz to 2 7 GHz Table 9 of IEC 60601 1 2 Ed 4 Table 9 of IEC 60601 1 2 Ed 4 Note NOTE 1 The higher frequency range applies to 80 MHz an...

Страница 34: ...complete medical system for local anesthesia with tumescent solution consisting of Liposat power medical infiltration pump for tumescence solution Vacusat power medical suction device Vibrasat power...

Страница 35: ......

Страница 36: ...ersion 019 01 05 M ller Medical GmbH Wasserkuppenstra e 29 31 36043 Fulda Germany Tel 49 0 661 94 19 5 0 Fax 49 0 661 94 19 5 850 www moeller medical com info moeller medical com Order number for Inst...

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