IEM Tel-O-Graph BT plus Скачать руководство пользователя

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Introduction

1.1

Clinical validation

The accuracy of the device's measurements has been
certified in accordance with ISO 81060-2:2013.

1.2

CE Mark

The Tel-O-Graph

BT plus meets the

requirements of the

▪

93/42/EEC (MDD),

▪

2014/53/EU (RED),

▪

2011/65/EU (RoHS) guidelines

and bears the CE mark.

IEM GmbH hereby declares that the Tel-O-Graph

plus corresponds to the 2014/53/EU (RED) guideline.

External reference

The complete text of the EU declaration of conformity
is available at the following website address:
www.iem.de.

1.3

Contents

▪

Blood pressure monitor

▪

Blood pressure cuff "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 circumference: 32-38 cm (12.6-15.0 in))

▪

Blood pressure cuff "XL"
(Arm circumference: 38-55 cm (15.0-21.7 in)

Содержание Tel-O-Graph BT plus

Страница 1: ...Operating manual EN Tel O Graph BT plus ...

Страница 2: ...llstr 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 published without the written approval of IEM GmbH IEM GmbH 2018 All rights reserved ...

Страница 3: ...batteries 19 5 3 Switching the blood pressure monitor on off 21 6 Measuring blood pressure and pulse 22 6 1 Before measuring 22 6 2 Putting the blood pressure cuff on 22 6 3 Correct posture 25 6 4 Measuring 26 6 5 Stopping the measurement 27 7 Transferring readings via Bluetooth 28 7 1 Active pairing Bluetooth modem 28 7 2 Passive pairing tablet smartphone 29 8 Memory 30 8 1 Saving readings 30 8 2...

Страница 4: ...plus can be integrated in tele monitoring systems that may involve different products for data transmission and storage Such products and the data base used to store and assess the blood pressure readings is not part of the Tel O Graph BT plus but is within the responsibility of the care provider that you have allowed to monitor your blood pressure readings You may not have direct access to the da...

Страница 5: ...lus corresponds to the 2014 53 EU RED guideline 1 External reference 2 The complete text of the EU declaration of conformity is available at the following website address www iem de 1 3 Contents Contents Blood pressure monitor Blood pressure cuff 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 ...

Страница 6: ...on as a result of the measured values without consulting your doctor Follow your doctor s instructions 2 2 Improper use The blood pressure monitor must not be used for newborns during surgery in the vicinity of MRI scanners or other strong magnetic fields or for clinical monitoring of patients and during transport of patients The blood pressure monitor must not be left within the reach of unsuperv...

Страница 7: ... event that successful blood pressure measurement 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 RF surgery monitors or for the clinical monitoring of patients such as on an intensive care unit Basic safety means that the patient cannot be endangered by any automatic device proc...

Страница 8: ...ng symbol in connection with the signal word WARNING indicates a possible or immediately threatening danger 5 Non adherence may lead to the mild moderate injuries or to the most severe injuries or death ATTENTION Short description of the danger 6 This warning symbol in connection with the signal word ATTENTION indicates possible material damage 7 Non adherence may lead to damage to the products or...

Страница 9: ...n when you have an intra vascular drip or arteriovenous AV shunt in your arm 15 WARNING Danger of tissue bleeding or haematoma When using the blood pressure monitor make sure it does not impede the blood circulation in your arm If you have sensitive bodily tissue despite the correct positioning of the cuff it can still result in tissue bleeding or haematoma If you are taking medication to alter bl...

Страница 10: ...he body as a mastectomy has been carried out 20 WARNING 21 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 further electrical medical device for monitoring on the same limb Only put the Tel O Graph BT plus on if you are not wearing any other medical electrical monitor on your arm 22 WARNING 23 Danger ...

Страница 11: ...WARNING Danger of strangulation by the cuff hose Persons including 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 monitor without supervision or instruction by a responsible person The blood pressure monitor may not be used by those with limited mental ...

Страница 12: ...requency surgery monitors Do not drop the blood pressure monitor and do not place objects on top of it Do not use the device directly adjacent to other devices or stacked with other devices as this may result in malfunction If operation in the manner described above becomes necessary nevertheless this device and the other devices should be monitored to ensure that they are functioning correctly Us...

Страница 13: ...esult of such a discharging and can result in the incorrect value being displayed ATTENTION Warranty Do not open the housing of the Tel O Graphs BT plus otherwise any warranty becomes void ATTENTION Batteries Remove the batteries from the battery compartment when they no longer have any charge or if you do not expect to use the blood pressure monitor for a longer period of time Do not throw batter...

Страница 14: ...d by CISPR You should therefore ensure that the Tel O Graphs BT plus is at least 30 cm 12 inches from any portable RF communications equipment ATTENTION 28 Fluid damage to the blood pressure monitor Liquid must not penetrate the device 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 mo...

Страница 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 ...

Страница 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 ...

Страница 17: ...Display 1 When this appears Battery empty 6 Number of pulse beats per minutes 2 Display of systolic upper value 7 Pulse detected 3 Data transfer 8 Number of measurement values 4 Bluetooth 9 Display of diastolic lower value 5 Infrared communication ...

Страница 18: ...tions 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 pressure monitor at an air humidity not condensing of 15 to 93 Extreme temperatures air humidity not condensing or heights can affect the performance of the blood pressure monitor ...

Страница 19: ... WARNING Risk of strangulation from the cuff hose and blood pressure cuff Keep the blood pressure cuff out of the reach of children 1 Unpack the entire 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 before use 3 Keep the packaging so that it can ...

Страница 20: ...ve the batteries and insert the batteries again 1 Open the battery cover on the underside of the blood pressure monitor 2 Insert four batteries AA alkaline with the poles aligned correctly 3 Close the battery cover The blood pressure monitor switches on automatically 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 th...

Страница 21: ... 5 3 Switching the blood pressure monitor on off Switching on Fig 6 Start screen 1 Press the button The display shows the start screen Fig 6 Switching off 2 The blood pressure monitor switches off automatically after about 5 minutes ...

Страница 22: ... quiet atmosphere for 5 minutes Always measure on the same arm normally your left Blood pressure 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 Risk of injury due to incorrectly connected air hose Do not kink knot or stretch the air hose WARNING The bl...

Страница 23: ...e socket on the left side of the blood pressure monitor and place the blood pressure monitor on the table see fig 7 2 Select the correct cuff size This depends on the upper arm circumference of the person whose blood pressure you will be measuring Upper arm circumference Cuff size 20 24 cm 7 9 9 5 in S 24 32 cm 9 5 12 6 in M 32 38 cm 12 6 15 0 in L 38 55 cm 15 0 21 7 in XL Note To obtain accurate ...

Страница 24: ... of the cuff features a clasp Pass the opposite end of the cuff through the clasp then fold it back over the clasp so that the two sides of the Velcro fastening meet Fig 8 Correct position of blood pressure cuff 5 Position the blood pressure cuff correctly see Fig 8 The hose must run down the middle of the inside of your lower arm towards your middle finger The lower edge of the cuff must be about...

Страница 25: ...rs 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 take the measurements Fig 9 Fig 9 Correct posture 1 Sit down comfortably on a chair to measure your blood pressure 2 Place your elbow on a table or a solid surface 3 Lean back in your chair 4 Hold your arm so that the blood pressure cuff is at ...

Страница 26: ... 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 pressure cuff and assume the correct posture 2 Press the button The display shows the start screen Fig 6 3 Press the button again to start the measurement The blood pressure monitor will confirm this with a short acoustic signal and briefly displays ...

Страница 27: ...proximately 10 seconds after measuring the blood pressure After the measurement 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 disruptions to blood flow Wait for at least 2 or 3 minutes to give your arteries time to return to their initial state 6 5...

Страница 28: ...ealthcare provider In the event of problems with data transfer if there are more than 15 readings any new readings will overwrite the oldest readings 7 1 Active pairing Bluetooth modem Note Pairing requires some basic familiarity with Bluetooth If you are not familiar with Bluetooth please contact your healthcare provider The Bluetooth connection is preconfigured but in the event of certain rare f...

Страница 29: ... display 5 Press the button The active pairing process will begin and PAI A and the symbols and will be shown on the blood pressure monitor display The data transfer device will be added to the device list automatically Note There should be only one other Bluetooth device in the surrounding area 7 2 Passive pairing tablet smartphone Note Pairing requires some basic familiarity with Bluetooth If yo...

Страница 30: ...een transferred to the database are saved If there are more than 15 readings the oldest data will be overwritten by the new readings 3 ATTENTION Data loss 4 To avoid data loss contact your healthcare provider before or when the display shows 15 measurements The number of readings is shown on the display Fig 10 Note Previously transmitted data is retained in the database and is not overwritten ...

Страница 31: ... see Fig 11A Note Every 3 seconds the display will automatically display the next menu option The display order is Infrared transmission IR Bluetooth transmission BT Active pairing PAI A Passive pairing PAI P Delete readings c lr Note The Infrared transmission IR menu option is intended for service personnel only 2 Wait until c lr flashes on the display Fig 11 C 3 Press the button You will hear an...

Страница 32: ...nd hold the button for more than 3 seconds The acoustic signal sounds 3 times and the display shows M00 see Fig 11 C The measurements are deleted The device returns to standby mode and displays the start screen see Fig 6 ...

Страница 33: ...of the Tel O Graph BT plus 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 lukewarm water up to 30 C at most to which you can add a mild detergent if necessary Never use abrasive or solvent based detergents as these can damage the surface of the blood pressure monitor and ...

Страница 34: ... of the clasp and spread the cuff out fully Remove the bladder and hose by pulling the bladder out of the bladder compartment via the slit provided for this purpose on the inside of the cuff ATTENTION To clean the bladder and hose use a mild fabric softener free laundry detergent and lukewarm water Do not use any other cleaning materials Ensure that no water gets into the bladder or hose Once the ...

Страница 35: ...opanol 70 Terralin Liquid Manufacturer Schülke Mayr When using other disinfectants not checked by IEM 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 with the skin To achieve the optimum effect apply the disinfectant to the cuff for at least five minutes Always allow the agents to dry ...

Страница 36: ...essionally 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 either IEM GmbH a competent authority or by authorised maintenance services corresponding to the Medizinprodukte Betreiber Verordnung Medical Product Operator Regulations Other than the metrological check no furthe...

Страница 37: ...re 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 legally bound to return used batteries You can return your old batteries to official collection points within your community or everywhere batteries of that type are sold Li Battery contains lithium...

Страница 38: ...ulse rate detected Put the blood pressure cuff on again Chapter 6 2 Err 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 Chapter 6 2 Err 3 Blood pressure beyond the measurement range If this notification appears continuously or repeatedly it is possibl...

Страница 39: ...ohol Err 6 Air congestion Check the blood pressure cuff for air congestion or a kink in the air hose If there is a kink in the air hose unkink it otherwise send the blood pressure monitor to your healthcare 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 Repl...

Страница 40: ...idual pressure in the blood pressure cuff Wait until the blood pressure cuff has deflated completely Err 10 Internal error If this error occurs repeatedly send the blood pressure monitor to your healthcare provider or directly to the manufacturer for checking ...

Страница 41: ...r 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 If this error occurs repeatedly contact your healthcare provider Cod 5 Invalid target data in EEPROM memory If this error occurs repeatedly contact your healthcare provider Cod 6 Hardware communication err...

Страница 42: ...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 accuracy 3 mmHg Pulse Rate Accuracy 2 or 3 BPM whichever is greater Memory 15 Measurements Power supply 6V 4x AA 1 5V alkaline Dimensions L x W x H 152 X 110 X 57 Mm Weight without batteries 325 G Material h...

Страница 43: ... pressure 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 connection Bluetooth Data transfer Class 1 Bluetooth in the case of 2 measurements per day with quality batteries alkaline ...

Страница 44: ...ufacturer 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 device everywhere in Europe Protect from rain and moisture Comply with the operating manual ...

Страница 45: ...omestic 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 bought the product Device is defibrillator safe The device emits electromagnetic waves This product has a Bluetooth interface Serial number ...

Страница 46: ...ply 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 during shipment to customer services Accessory parts subject to normal wear and tear cuff batteries etc Liability for direct or indirect consequential damages caused by the device is excluded even in the ev...

Страница 47: ... 11 Group 1 The Tel O Graph BT plus uses RF power exclusively for its internal function Its RF emission is therefore very low and it is unlikely that any neighbouring electronic device will experience any interference RF interference emissions according to CISPR 11 Class B The Tel O Graph BT plus is suitable for use in facilities other than residential areas and those directly connected to the pub...

Страница 48: ...discharge 15kV 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 RF radiated disturbances in accordance with IEC 61000 4 3 10 V m 80 MHz to 2 7 GHz 10 V m Do not use wearable or portable radio equipment closer to the Tel O Graph BT plus or its cables than the recommended safe distance The field ...

Страница 49: ...ronment guidelines IEC 61000 4 4 Not applicable IEC 61000 4 5 Not applicable IEC 61000 4 6 Not applicable Magnetic field at supply frequency 50 60 Hz in accordance with IEC 61000 4 8 30 A m 30 A m Magnet fields at mains frequency should match the typical values found in business and hospital environments IEC 61000 4 11 Not applicable ...

Страница 50: ...MHz 28 V m FM 5 kHz 1 kHz Sinus PM 18 Hz 704 787 MHz 9 V m PM 50 217 Hz 800 960 MHz 28 V m PM 50 18 Hz 1700 1990 MHz 28 V m PM 50 217 Hz 2400 2570 MHz 28 V m PM 50 217 Hz 5100 5800 MHz 9 V m PM 50 217 Hz 380 390 MHz 27 V m PM 50 18 Hz 430 470 MHz 28 V m FM 5 kHz 1 kHz Sinus PM 18 Hz 704 787 MHz 9 V m PM 50 217 Hz 800 960 MHz 28 V m PM 50 18 Hz 1700 1990 MHz 28 V m PM 50 217 Hz 2400 2570 MHz 28 V m...

Страница 51: ...Rev A 18 12 2018 ...

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