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61

EN

Annex

Guidance and manufacturer´s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environments listed below, and should 
only beused in such environments:

Emission test

Compatibility

Notes concerning the EM environment 

RF emissions CISPR 11

Group 1 

RF energy is used only to maintain device’s 
operation. Therefore, its RF emissions are so 
low that it’s not likely to cause any interference 
in nearby electronic equipment.

RF emissions CISPR 11 

Class B 

The device is suitable for use in all establish-
ments, including domesticestablishments, 
and those directly connected to the public 
low-voltage power supply networkthat supplies 
buildings used for domestic purposes.

Harmonic  emissions                                             
IEC 61000-3-2 

Class A 

Voltage 

fl

 uctuations / 

fl

 icker 

emissions IEC 61000-3-3 

complies 

Guidance and manufacturer´s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environments listed below, and should 
only beused in such environments:

Immunity test

IEC 60601 – 
test level

Compliance 
level

Electromagnetic environment - 
guidance

Electrostatic 
discharge (ESD) 
IEC 61000-4-2

± 6 kV contact 
± 8 kV air 

± 6 kV contact 
± 8 kV air 

Floors should be wood, concrete or 
ceramic tile. If 

fl

 oors are covered with 

synthetic material, the relative humidity 
should be at least 30 %.

Power frequency
(50/60 Hz) 
magnetic 

fi

 eld    

IEC 61000-4-8 

3 A/m 

3 A/m 

The power frequency magnetic 

fi

 eld 

should be measured at the intended 
place of installation in order to ensure 
that it is low enough.

Recommended separation distances between portable and mobile RF communication

The device is intended for use in an electromagnetic environment where radiated RF 
disturbancesare under control. User can help prevent electromagnetic interference by keeping 
the device at a minimum distance from portable and mobile RF communications equipment 
(transmitters). Below table details the maximum output power of transmitter:

Rated maximum 
output power 
of transmitters 
in Watt

Seperation distance according to frequency of transmitter / m

150 kHz to 80 MHz
d = 1.2 

P

80 MHz to 800 MHz
d = 1.2 

P

800 MHz to 2.5 GHz 
d = 2.3 

P

0.01
0.1
1
10
100

0.12 
0.38 
1.2 
3.8 
12

0.12 
0.38 
1.2 
3.8 
12

0.23 
0.73 
2.3 
7.3 
23

For transmitters rated at a maximum output power not listed above, the recommended separa-
tion distance d in metres (m) can be estimated 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 the transmitter manufacturer.

NOTE 1:

At 80 MHz and 800 MHz the higher frequency range should be used.

NOTE 2:

These guidelines may not be applicable in all situations. Electromagnetic 
propagation is in

fl

 uenced by absorption and re

fl

 ection from buildings, ob-

jects and people.

Содержание Active Control+

Страница 1: ...EN Digital Blood Pressure Monitor for the Upper Arm INSTRUCTIONS FOR USE GT 1115...

Страница 2: ...of Display 43 Preparation for Use Power Supply and Charge Power 44 Activate your blood pressure monitor 44 Setting Date and Time 47 Selecting a User 48 Attaching the Pressure Cuff 49 Measuring Posture...

Страница 3: ...easuring method to detect blood pressure Before every measurement the unit establishes a zero pressure equivalent to the air pressure Then it starts inflating the cuff meanwhile the unit detects press...

Страница 4: ...peutic measures on the basis of a self measurement Never alter the dose of a medi cine prescribed by a physician Consult your physician if you have any questions about your blood pressure Please keep...

Страница 5: ...IN EN ISO 10993 10 The constituent materials do not have the potential to produce any ir ritation or allergic reactions Do not use the cuff on damaged skin Do not use the device in the case of known a...

Страница 6: ...ll repair it free of charge With the exception of the battery and cuff all parts of the unit are subject to this warranty Damage caused by im proper handling of your unit is not guaranteed In the even...

Страница 7: ...ification chart re leased by the WHO World Health Organization for eva luation of your blood pressure level Diastolic mmHg Systolic mmHg 130 180 170 160 150 140 120 80 85 90 95 100 105 110 Severe Hype...

Страница 8: ...neral a lower blood pressure reading is better un less it causes unpleasant symptoms such as fainting and or lightheadedness Fluctuation and variation in blood pressure The following chart shows possi...

Страница 9: ...rregularities occur the arrhythmia icon appears on the display along with the blood pressure readings CAUTION The appearance of the arrhythmia icon indicates that a pulse irregularity consistent with...

Страница 10: ...to 16 5 inches MEM button START button LCD Display USB Ppower interface Cuff Air Hose Air connector plug Air connector plug Content 1 Blood pressure monitor GT 1115 2 Cuff Type BF applied part 22 cm...

Страница 11: ...erage value The average value of the latest 3 blood pressure measurement results Low battery Battery is low and need to be charged Arrhythmia Irregular heartbeat detection WHO classifi cation WHO eval...

Страница 12: ...with a USB connection not included or another source of power with a USB connection and the enclosed USB cable for charging the rechargeable battery as shown in the following il lustrations AC adaptor...

Страница 13: ...h off automatically and you must recharge it imme diately During recharging the LCD display flashes and shows the following symbols If it is not charged at all the following symbols appear on the LCD...

Страница 14: ...aler If you measure your blood pressure three times a day the unit can be used for up to 25 days without recharging Do not use the blood pressure monitor during the recharging process When the unit is...

Страница 15: ...o that a time stamp can be assigned to each record that is stored in the memory time format 24 H 1 When the monitor is off hold pressing MEM button about 3 seconds to enter the mode for year setting 2...

Страница 16: ...he settings you have done and then turn off Select User 1 When the monitor is off press and hold START button to enter user setting mode The user ID will blink 2 Then press MEM button to select the us...

Страница 17: ...ge of the cuff should be approxi mately 2 5 centi metres from the crook of the arm 3 Attach the cuff on the right arm if it is not possible to measure on the left arm Posture during measurement 1 Sit...

Страница 18: ...tomatically 2 As soon as measurement is completed the blood pressure and pulse readings appear on the display Press the START button to switch the unit off Oth erwise the unit will switch off automati...

Страница 19: ...e stored reading can be seen in the bottom left hand corner The stored reading appears alternate ly with the time when the reading was taken The most recent record 1 is shown first Each new measuremen...

Страница 20: ...en the unit is already in memory mode The user and dEL ALL delete all appears on the display 2 Press the MEM button to confirm the deletion process dEL dOnE deletion done appears on the display 3 To c...

Страница 21: ...maintenance Do not drop the unit Do not modify or dis assemble the unit or the arm cuff Do not twist the cuff Use a cloth moistened with water or neutral detergent to clean the body of the unit and th...

Страница 22: ...oid thinner benzine and other harsh cleaners Keep the unit in a suitable place Avoid high tempe rature direct sunlight high moisture and dust Do not press the START button if the cuff has not been pro...

Страница 23: ...me re fasten the cuff and measure the blood pressure again E10 or E11 The unit has de tected movement or pulse rate is too low Rest for a short time and retake the meas urement E20 No pulse signal is...

Страница 24: ...SYS 60 mmHg 230 mmHg 8 0 kPa 30 7 kPa DIA 40 mmHg 130 mmHg 5 3 kPa 17 3 kPa Pulse value 40 199 beat minute Accuracy Pressure 3 mmHg 0 4 kPa Pulse value 5 Normal working condition 5 C to 40 C Relative...

Страница 25: ...57 EN Specifications Degree of protection IP20 Device classifi cation Battery mode with built in lithium ion rechargeable battery Subject to changes in the interests of technical progress...

Страница 26: ...ssential performance IEC EN 60601 1 11 Medical electrical equipment Part 1 11 General requirements for basic safety and essential performance Collateral standard Requirements for medical electrical eq...

Страница 27: ...facture date Direct current Clinical investigation DIN EN ISO 81060 2 Non invasive sphygmomanometers Part 2 Clinical investigation of automated measurement type ISO 81060 2 Usability IEC EN 60601 1 6...

Страница 28: ...ements for EMC electromagnetic compatibility and defines the levels of immunity to electromagnetic interference and the maximum electromagnetic emission levels for medi cal devices This blood pressure...

Страница 29: ...lative humidity should be at least 30 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m The power frequency magnetic field should be measured at the intended place of installation in o...

Страница 30: ...netic propaga tion is affected by absorption and reflection from structures objects and people Guidance and manufacturer s declaration electromagnetic immunity a Field strengths from fixed transmitter...

Страница 31: ...63 EN Geratherm Medical AG Fahrenheitstra e 1 98716 Geschwenda Germany www geratherm com...

Страница 32: ......

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