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ELECTROMAGNETIC COMPATIBILITY INFORMATION 

 

Table 1   For all ME EQUIPMENT and ME SYSTEMS 

Guidance and manufacture’s declaration 

- electromagnetic emissions 

This device is intended for use in the electromagnetic environment specified below. 
The customer or the user of this device should assure that it is used in such an environment. 
Emissions test 

Compliance 

Electromagnetic environment - guidance 

RF emissions 
CISPR 11 

Group 1 

This  device  uses  RF  energy  only  for  its  internal 
function. Therefore, its RF emissions are very low and 
are  not  likely  to  cause  any  interference  in  nearby 
electronic equipment. 

RF emissions 
CISPR 11 

Class B 

This  device  is  suitable  for  use  in  all  establishments, 
including domestic establishments and those directly 
connected  to  the  public  low-voltage  power  supply 
network  that  supplies  buildings  used  for  domestic 
purposes. 

Harmonic emissions 
IEC 61000-3-2 

Class A 

Voltage fluctuations/ 
flicker emissions 
IEC 61000-3-3 

Complies 

Guidance and manufacturer’s declaration 

- electromagnetic immunity 

This  device  is  intended  for  use  in  the  electromagnetic  environment  specified  below.  The 
customer or the user of this device should assure that it is used in such an environment. 
Immunity Test 

IEC 60601 Test 
level 

Compliance level 

Electromagnetic environment - 
guidance 

Electrostatic 
discharge (ESD) 
IEC61000-4-2 

 

± 6 kV contact 

± 8 kV air 

± 6 kV contact 

± 8 kV air 

Floors should be wood, concrete 
or  ceramic  tile.  If  floors  are 
covered  with  synthetic  material, 
the  relative  humidity  should  be 
at least 30 %. 

Power frequency 
(50/60 Hz) magnetic 
field IEC61000-4-8 

 

3 A/m 

3 A/m 

Power frequency magnetic fields 
should be at levels characteristic 
of a typical location in a typical 
commercial or hospital 
environment. 

NOTE: U

T

 is the a.c. mains voltage prior to application of the test level. 

 

 

 
 
 
 

 

Summary of Contents for MBG10-6/0741

Page 1: ...MBG10 6 0741 Blood Glucose Monitor Instruction Manual Please read all instructions carefully and retain for future use...

Page 2: ...uction for Use Before Use Setting the monitor 6 Delete Memory 7 Instruction for Use 8 About Color Bars 10 Physical and Performance Deterioration 11 Alternative Site Testing Care and Maintenance 12 Uni...

Page 3: ...r MBG10 6 0741 to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips palm forearm upper arm calf or thigh MEDICAL DISCLAIMER This device and manual are not...

Page 4: ...y the manufacturer All parts of the system are considered biohazards and can potentially transmit infectious diseases even after you have performed cleaning and disinfection Refer to the resources ide...

Page 5: ...ates that the result will not be stored in the memory Measurement Unit Appears with the test result either in mg dL or mmol L Low Battery Appears when battery is low Alarm Clock 4 Memories for Alarm B...

Page 6: ...lts The lancing device is for self use only Do not share or re use lancets Please refer to the Lancing Device Manual for the detailed procedure Battery Installation 1 Open the battery compartment at t...

Page 7: ...ss M to add an hour When the correct hour is set press S to confirm When the minute flashing press M to add one minute Hold M longer to add minutes faster When the correct minute is set press S to con...

Page 8: ...and lancing device A sample may be obtained from the finger by the following steps 1 Wash your hands all the time before the following steps 2 Insert the test strip into the monitor s strip port with...

Page 9: ...he countdown from 5 to 1 begins on the monitor display 3 Test result will appear on the monitor Note The results obtained from the glucose monitor are plasma calibrated This helps you and your physici...

Page 10: ...ng press the MEM button for 3 seconds to view the test results stored in the monitor The first reading is your recent 7 day average blood glucose result 2 Press MEM button to review 7 14 21 28 60 and...

Page 11: ...Site Testing Food medication illness stress and exercise can affect blood glucose levels Capillary blood from the fingertips reflects these changes faster than capillary blood from other sites Therefo...

Page 12: ...nd disinfection can avoid the infection to you or to the other people and the cross infection The monitor and lancing device should be cleaned and disinfected following each use The monitor and the la...

Page 13: ...ece mg dL Norway mmol L India mg dL Qatar mmol L Indonesia mg dL Russia mmol L Israel mg dL Singapore mmol L Italy mg dL Slovakia mmol L Japan mg dL South Africa mmol L Jordan mg dL Sub Saharan Africa...

Page 14: ...level is higher than600mg dL 33 3mmol L The message indicates severe hyperglycemia high blood glucose Seek immediate medical assistance The battery in your monitor in low on power Please change the ba...

Page 15: ...t enough sample in the test strip 2 Test strip has expired 3 Test strip has been damaged due to heat or humidity so that the sample cannot be applied or the speed of application is too slow 4 System i...

Page 16: ...ork that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and manufacturer s declaration el...

Page 17: ...mitters 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 followi...

Page 18: ...ration distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to...

Page 19: ...rmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance to the Instructions may cause harmful...

Page 20: ...illary whole blood Blood Volume Minimum 0 7 micro liter Life Span 5 Years CALIBRATION AND SERVICE The accuracy of this blood pressure monitor has been carefully tested and is designed for a long servi...

Page 21: ...844 0 9812 0 985 System accuracy results for glucose concentrations 75 mg dL Anatomical site Within 5 mg dL Within 10 mg dL Within 15 mg dL Within 20 mg dL Finger 31 55 56 4 51 55 91 1 55 55 100 55 55...

Page 22: ...ay warranty period a product with a defect will be either repaired or replaced with a reconditioned comparable model at manufacturer s option The repaired or replacement product will be in warranty fo...

Page 23: ...tort contractor commercial law including but not limited to negligence gross negligence strict liability breach of warranty and breach of contract Under no circumstances will Manufacturer s Distribut...

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