background image

59

EN

Symbol index

Follow the instructions 
for use

Type BF Equipment

Keep dry

Manufacturer

93 %

10 %

Store at relative humid-
ity levels between
10 % and 93 % R.H.

Batch code 
(YYMMXXX; month/ 
year/identi

fi

 cation 

number)

-20 °C

+60 °C

Store between
-20 °C und +60 °C

Caution! Read the user 
manual

The device must not 
be disposed of with 
household waste

Manufacture 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 
Medical electrical equipment - Part 1-6: 
General requirements
for basic safety and essential performance 
- Collateral Standard: Usability
IEC/EN 62366 
Medical devices - Application of usability 
engineering to medical devices

Software life-cycle 
processes

IEC/EN 62304 +AC 
Medical device software - Software life 
cycle processes

Quality standard

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: ......

Отзывы: