Mechan PLA-600 User Manual Download Page 20

DOC. MEUM-131205700. Version 01

Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY –

for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacturer’s declaration – electromagnetic immunity

The PLA-600 is intended for use in the electromagnetic environment specified below. The

customer or the user of the PLA-600 should assure that it is used in such an environment.

Immunitytest

IEC 60601

test level

Compliance

level

Electromagnetic environment - guidance

Conducted RF

IEC 61000-4-6

Radiated

RFIEC

61000-4-3

3 Vrms

150 kHz to

80MHz

3 V/m

80 MHz to

2.5 GHz

3 V

3 V/m

Portable and mobile RF communications equipment
should be used no closer to any part of the Models
PLA-600, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.

Recommended separation distance

where P is the maximum output power rating of the
transmitter in watts (W) according to thetransmitter
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

ofequipment 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.

a

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
predictedtheoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Model PLA-600 are used exceeds the applicable RF compliance level above, the
Model PLA-600 should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the Model PLA-600.

b

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

Summary of Contents for PLA-600

Page 1: ...logy Co Ltd No 11 District 9 Huayin Industrial Harbor No 618 West Kelin Road Chengdu Straits Science Tech Industrial Development Park Wenjiang District Chengdu China Customer Service 400 666 0366 Emai...

Page 2: ...Electronic Technology Co Ltd with all rights reserved No part of this document may be used reproduced transmitted processed or recorded by any means or form electronic mechanical photographic or othe...

Page 3: ...CH 3 7 3 1 CONNECTION GRAPH 3 3 2 WORKING PRINCIPLE 3 4 3 2 1 Principle 3 3 2 2 How It Works 3 4 3 2 3 Drawing of Principle 4 3 3 SYSTEM STRUCTURES AND CONFIGURATION INTRODUCTION 5 7 3 3 1 Introductio...

Page 4: ...ortation 10 5 6 2 Storage 10 5 7 REGULATIONS ON SCRAPED EQUIPMENT 10 SECTION 6 SYSTEM SPECIFICATIONS 11 6 1 TECHNICAL SPECIFCIATION 11 6 1 1 Treatment Handle 11 6 1 2 Host Device 11 6 1 3 Power Output...

Page 5: ...and turning on the unit To correct it please do as follows A Change the place of unit B Put the unit farther away from the influenced devices C Connect the unit to different electrical outlet or elect...

Page 6: ...Attention Provides important matters requiring attention at first Section 1 Shows the purpose and organization of this manual Section 2 Describes the general configuration clinical indication and con...

Page 7: ...re use the handle should be disinfected And there are bipolar and multi polar probes supplied 2 2 Clinical Indication and Contraindication 2 2 1 Indication Urology Surgeries BPH etc 2 2 2 Contraindica...

Page 8: ...flows through human body to reach the electrode plate attached to patient thus making the energy through human body and surrounding tissues get much larger 3 2 2 How it Works To transmit the energy t...

Page 9: ...nit Output Interface Chip Drive Display Sound Instruction Picture 1 The picture 1 shows the main structures of this device Signals are formed in the vibration unit and then output is realized in isola...

Page 10: ...igns refers to the Mark of Flow Control Unit refers to the Mark of Protection Class ours is CF type refers to Footswitch Connection refers to Volume Adjustment at the Host Machine refers to Power Supp...

Page 11: ...sion 01 3 3 2 Control Keys and Marking of the Host Device Shown with Graph 1 Manufacturer Logo 2 Four Pads 3 Socket for Footswitch 4 Socket for Treatment Handle 2 3 16 15 14 13 4 6 5 7 8 9 10 11 12 19...

Page 12: ...output is closed operator can press the keys for change 13 Display of time After the device is started it will show the work time 14 Power Supply Display Light Green After power on the light is green...

Page 13: ...to the socket at the front of host device and rotate it tightly 4 Plug the treatment handle into the corresponding socket of the device Before use make sure the treatment handle is cleaned and disinf...

Page 14: ...il reaching the highest of 10 Gear After 10 the system will go back to 1 Gear 2 To reduce the gear position power output value press the key to reduce the voltage level of the corresponding mode Each...

Page 15: ...the marking of Upwards Handle with Care Weather Proof 5 6 2 Storage This device should be stored in a well ventilated room without corrosive gas The height above ground and the distance from wall sho...

Page 16: ...est Weight 10KG Height 19CM Width 39CM Length 45CM 6 1 5 Footswitch Cable length 4 5m Cleanness way anhydrous ethanol 6 2 System Classifications and Security Statement 6 2 1 System Classification As p...

Page 17: ...curity Statement This unit meets the requirements of Term 19 1 19 2 and 19 3 of GB9706 1 2007 and GB9706 4 2009 Leakage electricity Grounding 200 A Leakage electricity Patients 20 A The unit can be us...

Page 18: ...st Compliance Electromagnetic environment guidance 4 RF emissions CISPR 11 Group 1 The Model PLA 600 uses RF energy only for its internal function Therefore its RF emissions are very low and are not l...

Page 19: ...ospitalenvironment Surge IEC 61000 4 5 1 kV differential mode 2 kV 1 kV differential mode 2 kV common mode common mode Mains power quality should be that of a typical commercial or hospitalenvironment...

Page 20: ...es 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 vicin...

Page 21: ...odel PLA 600 as recommended below according tothe maximum output power of the communications equipment Rated maximum output of transmitter W Separation distance according to frequency of transmitter m...

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