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60

EN

Information on electromagnetic compatibility (EMC)

Electronic devices such as PCs and mobile phones can 
lead to the exposure of medical devices in operation to 
electromagnetic interference from other devices. This can 
lead to malfunction of the medical device and create a 
potentially unsafe situation.
Medical devices should also not interfere with any other 
devices.

The EN 60601-1-2 standard regulates the requirements 
for EMC (electromagnetic compatibility) and de

fi

 nes  the 

levels of immunity to electromagnetic interference and  
the maximum electromagnetic emission levels for medi-
cal devices.

This blood pressure monitor, which is manufactured by 
Geratherm Medical AG, complies with the EN 60601-1-2 
standard in relation to both immunity and emissions.

However, special precautions should be observed:

Please only use the device indoors and not in the vici- 
nity of mobile phones or microwave ovens. In the case 
of devices whose maximum power exceeds 2 W, the 
minimum distance from your blood pressure monitor 
should be 3.3 metres.

Annex

Summary of Contents for Active Control+

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 32: ......

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