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Table of contents 

EN 

Table of contents  

Table of contents ...................................................... 3

 

1

 

Introduction ...................................................... 4

 

1.1

 

Clinical validation .............................................. 4

 

1.2

 

CE Mark ............................................................ 4

 

1.3

 

Contents ........................................................... 5

 

2

 

Instructions for use ......................................... 6

 

2.1

 

Intended use ..................................................... 6

 

2.2

 

Improper use..................................................... 6

 

2.3

 

Essential Performance ..................................... 7

 

3

 

Safety................................................................. 8

 

3.1

 

Explanation of the safety symbols .................... 8

 

3.2

 

Important patient information ............................ 9

 

3.3

 

Important device instructions .......................... 12

 

4

 

Description of device ..................................... 15

 

4.1

 

Blood pressure monitor .................................. 15

 

4.2

 

Blood pressure cuff ......................................... 16

 

4.3

 

Display ............................................................ 17

 

4.4

 

Ambient conditions ......................................... 18

 

5

 

Preparing the measurement ......................... 19

 

5.1

 

Unpacking ....................................................... 19

 

5.2

 

Inserting the batteries ..................................... 19

 

5.3

 

Switching the blood pressure monitor on/off .. 20

 

6

 

Measuring blood pressure and pulse .......... 21

 

6.1

 

Before measuring ........................................... 21

 

6.2

 

Putting the blood pressure cuff on ................. 21

 

6.3

 

Correct posture ............................................... 23

 

6.4

 

Measuring ....................................................... 24

 

6.5

 

Stopping the measurement ............................ 25

 

7

 

Transmitting the measurement values via 
Bluetooth

®

....................................................... 26

 

7.1

 

Active Pairing (Bluetooth modem).................. 26

 

7.2

 

Passive Pairing (Tablet, Smartphone) ........... 27

 

8

 

Memory ........................................................... 28

 

8.1

 

Saving readings .............................................. 28

 

8.2

 

Deleting readings from the blood pressure 
monitor ............................................................ 28

 

9

 

Cleaning and disinfection ............................. 30

 

9.1

 

Cleaning ......................................................... 30

 

9.2

 

Disinfection ..................................................... 31

 

10

 

Maintenance ................................................... 32

 

11

 

Disposal .......................................................... 33

 

12

 

Error messages .............................................. 34

 

12.1

 

Blood pressure measurement errors ............. 34

 

12.2

 

Communication error ...................................... 36

 

13

 

Technical data and symbols ......................... 37

 

14

 

Warranty and repairs ..................................... 41

 

15

 

Manufacturer’s EMC guidelines ................... 42

 

 

Summary of Contents for Tel-O-Graph BT

Page 1: ...EN Tel O Graph BT Operating instructions...

Page 2: ...bH I E M GmbH Cockerillstr 69 52222 Stolberg Germany Telephone 49 2402 9500 0 Fax 49 2402 9500 11 E mail info iem de Website www iem de The content of this operating manual must not be reproduced or p...

Page 3: ...s 19 5 3 Switching the blood pressure monitor on off 20 6 Measuring blood pressure and pulse 21 6 1 Before measuring 21 6 2 Putting the blood pressure cuff on 21 6 3 Correct posture 23 6 4 Measuring 2...

Page 4: ...ood pressure monitor and also use later If you have any questions about our services or products feel free to contact us 1 1 Clinical validation The accuracy of the device s measurements has been cert...

Page 5: ...M Arm circumference 24 32 cm 9 5 12 6 in Operating manual Batteries 4x AA alkaline Optional accessories Blood pressure cuff S Arm circumference 20 24 cm 7 9 9 5 in Blood pressure cuff L Arm circumfer...

Page 6: ...without consulting your doctor Follow your doctor s instructions 2 2 Improper use The blood pressure monitor must not be used for newborns during operations in the vicinity of MRI scanners or other st...

Page 7: ...surement is impossible The blood pressure monitor does not emit an alarm in the sense of IEC 60601 1 8 The blood pressure monitor is not provided to be used in conjunction with HF surgery monitors or...

Page 8: ...his warning symbol in connection with the signal word WARNING indicates a possible or immediately threatening danger Non adherence may lead to the mild moderate injuries or to the most severe injuries...

Page 9: ...en you have an intra vascular drip or arteriovenous AV shunt in your arm WARNING Danger of tissue bleeding or haematoma When using the blood pressure monitor make sure it does not impede the blood cir...

Page 10: ...the body as a mastectomy has been carried out WARNING Danger of a temporary loss of function of a present electrical medical device as a result of putting on or pumping up a cuff if you are wearing a...

Page 11: ...g children who are unable to use the blood pressure monitor safely due to their physical sensory or mental capabilities or their inexperience or lack of knowledge must not use this blood pressure moni...

Page 12: ...e becomes necessary nevertheless this device and the other devices should be monitored to ensure that they are functioning correctly The use of components not included in the scope of delivery may lea...

Page 13: ...lectric fields Measurements may be faulty if the device is operated in the vicinity of strong electrical fields Do not operate the blood pressure monitor near High voltage power lines Microwave device...

Page 14: ...If you believe that liquid has penetrated the device during cleaning or use of the blood pressure monitor the device must no longer be used If the blood pressure monitor is exposed to moisture switch...

Page 15: ...Description of device 15 EN 4 Description of device 4 1 Blood pressure monitor Fig 1 Blood pressure monitor 1 Display 4 Battery cover 2 Infrared interface for service 5 Air hose socket 3 button...

Page 16: ...Description of device 16 4 2 Blood pressure cuff Fig 2 Blood pressure cuff 1 Blood pressure cuff 2 Air hose 3 Air hose connection...

Page 17: ...play 1 When this appears Battery empty 6 Number of pulse beats per minutes 2 Display of systolic upper value 7 Pulse detected 3 Data transmission 8 Number of measurement values 4 Bluetooth 9 Display o...

Page 18: ...ions Never store the blood pressure monitor outside a temperature range of 25 C to 70 C Never use the blood pressure monitor outside a temperature range of 5 C to 40 C Only store or use the blood pres...

Page 19: ...delivery package and check that everything is present 2 Inspect the blood pressure monitor to ensure there is no visible damage on the outside If the blood pressure monitor is damaged have it repaired...

Page 20: ...carries out a display test and displays the start screen see Fig 5 and Fig 6 WARNING Make sure that all segments are displayed by the screen Inform your healthcare provider if the display is damaged F...

Page 21: ...re changes over the course of the day Measurements are only comparable when they are measured at the same time of day and under the same circumstances 6 2 Putting the blood pressure cuff on WARNING Ri...

Page 22: ...irectly against your skin 3 Insert your left arm into the blood pressure cuff Fig 8 Correct position of blood pressure cuff 4 Position the blood pressure cuff correctly see Fig 8 The hose must run dow...

Page 23: ...oom to insert your index and middle fingers between the skin and the material of the blood pressure cuff 6 3 Correct posture After positioning the blood pressure cuff assume the correct posture to tak...

Page 24: ...ries during measurement Do not place the air hose around your neck If you feel any pain during the measurement stop the measurement Do not place the blood pressure cuff over wounds 1 Apply the blood p...

Page 25: ...nt all the air is let out of the blood pressure cuff The display shows your blood pressure and your pulse rate 4 Remove the blood pressure cuff WARNING Taking measurements too frequently can result in...

Page 26: ...ontact your healthcare provider In the event of transmission problems if there are more than 15 readings the oldest data is overwritten by the new readings in the monitor 7 1 Active Pairing Bluetooth...

Page 27: ...ait until the display shows PA A and the symbol 5 Press the button Active pairing begins and the display of the blood pressure monitor displays PA A und the and symbols The transmission device is auto...

Page 28: ...than 15 readings the oldest data will be overwritten by the new readings Note The data in the database is retained and is not overwritten The number of readings is shown on the display Fig 10 8 2 Dele...

Page 29: ...ansmission IR is provided for servicing purposes and you do not need to use it 2 Wait until c lr flashes on the display Fig 11 C 3 Press the button You will hear an acoustic signal and the display wil...

Page 30: ...f the Tel O Graphs BT otherwise any warranty becomes void Note Always observe the manufacturer s instructions on the disinfection and cleaning of these products 9 1 Cleaning ATTENTION To clean use luk...

Page 31: ...er disinfectants not checked by I E M GmbH the user is responsible for the proof of use without damage Never use disinfectants which leave residue on the product or which are not suitable for contact...

Page 32: ...e is used professionally In certain countries this requirement may be regulated by national laws or regulations The metrological check comes at an additional cost and can be carried out in Germany by...

Page 33: ...e about this from your local authority the communal disposal companies or the shop in which you bought the product Batteries Batteries must not be disposed of with domestic waste As a consumer you are...

Page 34: ...2 Arm moved during measurement Keep your arm still during the measurement Chapter 6 3 The blood pressure cuff is not correctly positioned on your arm Check the placement of the blood pressure cuff Cha...

Page 35: ...provider or the manufacturer Blood pressure cuff incorrectly connected Connect the blood pressure cuff to the blood pressure monitor Chapter 6 2 Leak in the blood pressure cuff or air hose Replace the...

Page 36: ...vider Cod 3 Could not send readings Take another measurement and check whether the readings are transmitted If this error occurs repeatedly contact your healthcare provider Cod 4 Communication error I...

Page 37: ...lator safe Specification Value Unit Measuring method Oscillometric Blood pressure measurement range Systolic 60 to 290 Diastolic 30 to 195 mmHg Pulse measurement range 30 to 240 1 min Pressure accurac...

Page 38: ...ssure 700 to 1060 hPa Transport temperature 25 to 70 C Storage temperature 25 to 70 C Air humidity not condensing operation transport and storage 15 to 93 Battery capacity c 500 Measurements Data conn...

Page 39: ...nufacturer Date of manufacture YYYY MM DD Designation of the FCC radio authorisation CE 0044 Labelling of a medical device in accordance with directive 93 42 EEC It may not be possible to use the devi...

Page 40: ...c waste but should be taken to a recycling point for electric and electronic devices You can find out more about this from your local authority the communal disposal companies or the shop in which you...

Page 41: ...mply with the operating manual Damage resulting from maintenance or intervention by the purchaser or unauthorised third parties Transport damage en route from the manufacturer to the consumer or durin...

Page 42: ...emissions according to CISPR 11 Group 1 The Tel O Graph BT uses HF power exclusively for its internal function Its HF emission is therefore very low and it is unlikely that any neighbouring electroni...

Page 43: ...air discharge 6kV contact discharge 8kV air discharge Floors should consist of wood or cement or ceramic tiles If the floor consists of synthetic materials relative humidity must be at least 30 IEC 6...

Page 44: ...mission frequency Recommended safety distance d 1 2 P W for 80 Mhz to 800 Mhz d 2 3 P W for 800 Mhz to 2 5 Ghz where P maximum nominal output of the transmitter in watts as per the transmitter manufac...

Page 45: ...teur radio stations AM and FM radio and TV transmitters cannot theoretically be accurately determined in advance In order to determine the electromagnetic environment in relation to stationary transmi...

Page 46: ...transmitter P in W 80 Mhz to 800 Mhz d 1 2 P W 800 Mhz to 2 5 Ghz d 2 3 P W 80 kHz to 80 MHz 0 01 0 12 0 23 Not applicable 0 1 0 38 0 73 Not applicable 1 1 2 2 3 Not applicable 10 3 8 7 3 Not applicab...

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