IEM Tel-O-Graph BT Instructions For Use Manual Download Page 5

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Introduction

Clinical Validation

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

CE Mark

The Tel-O-Graph

BT meets the requirements of the

▪

93/42/EEC (MDD),

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2014/53/EU (RED),

▪

2011/65/EU (RoHS) guidelines

and bears the CE mark.

IEM GmbH hereby declares that the Tel-O-Graph

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

The complete text of the EU declaration of conformity is available at the following website address:

https://www.iem.de/doc/

Accessories

Medical accessories

▪

Blood pressure cuff "S" (Arm circumference:20-24 cm (7.9-9,5 in))

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Blood pressure cuff "M" (Arm circumference: 24-32 cm (9.5-12.6 in))

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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)

▪

HMS CS

General accessories

▪

Batteries (4x, AA, alkaline)

▪

USB-Bluetooth

-Adapter

▪

IEM set pouch

Summary of Contents for Tel-O-Graph BT

Page 1: ...Gebrauchsanweisung DE Instructions for Use EN Manual de instrucciones ES Mode d emploi FR Istruzioni per l uso IT Gebruiksaanwijzing NL ...

Page 2: ...evice to sale by or on the order of a physician IEM GmbH Gewerbepark Brand 42 52078 Aachen Germany Email Website info iem de www iem de The content of this instructions for use must not be reproduced or published without the written approval of IEM GmbH IEM GmbH 2021 All rights reserved ...

Page 3: ...ies 22 Switching the blood pressure monitor on off 23 6 Measuring blood pressure and pulse 24 Before measuring 24 Putting the blood pressure cuff on 24 Correct posture 28 Measuring 29 Stopping the measurement 30 7 Transferring readings via Bluetooth 31 Active Pairing Bluetooth Modem 31 Passive Pairing HMS CS 33 8 Memory 34 Saving readings 34 Delete readings from the device 35 9 Cleaning and disinf...

Page 4: ...al Various forms of pulse wave analysis can be enabled at any time The Tel O Graph BT 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 but is within the responsibility of the care provider physician that you have al...

Page 5: ...responds to the 2014 53 EU RED guideline The complete text of the EU declaration of conformity is available at the following website address https www iem de doc Accessories Medical accessories Blood pressure cuff S Arm circumference 20 24 cm 7 9 9 5 in Blood pressure cuff M Arm circumference 24 32 cm 9 5 12 6 in Blood pressure cuff L Arm circumference 32 38 cm 12 6 15 0 in Blood pressure cuff XL ...

Page 6: ...undertake any treatment and or take medication as a result of the measured values without consulting your physician Follow your physician s instructions Improper Use The blood pressure measuring device must not be used for newborn infants or children under the age of 12 must not be used for surgery must not be used near a magnetic resonance imaging scanner or other strong magnetic field and must n...

Page 7: ...ange value in blood pressure determination according to IEC 80601 2 30 Power delivery pressure supply to the cuff within the set limits according to IEC 80601 2 30 An error is issued in the 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 conjunctio...

Page 8: ...n disorders or arteriosclerosis Explanation of the safety symbols WARNING Short description of the danger This 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 or death ATTENTION Short description of the danger This warning symbol in connection with th...

Page 9: ...of self diagnosis Do not undertake any changes to your treatment and or take medication due to the measured values without consulting your physician Follow your physician s instructions WARNING Danger of blood flow disruptions as a result of putting on and pumping up a cuff on limbs with an intra vascular drip or intra vascular treatment or with an arteriovenous AV shunt If you have an intra vascu...

Page 10: ...nsult your physician before using the blood pressure monitor WARNING Danger of injury as a result of allergic reactions to the cuff material In the event of pain or allergic reactions remove the cuff Pay attention to hygiene concerns WARNING Danger of injury as a result of using unapproved accessories Only use accessories approved by the manufacturer and distributed by the trader or manufacturer R...

Page 11: ...if you are wearing a further electrical medical device for monitoring on the same limb Only apply the Tel O Graph BT cuff if you are not wearing any other medical electrical device on this arm WARNING Danger of fluid occurrence when using the batteries incorrectly Liquid that escapes from the batteries due to mishandling can cause skin irritation If you come into contact with the liquid rinse it a...

Page 12: ...NG 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 compe...

Page 13: ...age by pressing the button This deflates the cuff and the cuff can be removed WARNING Risk of injury if used on patient groups for whom this device is not intended The Tel Graph BT is not intended for use on women who are pregnant or those with pre eclampsia ...

Page 14: ...ld be monitored to ensure that they are functioning correctly Use of components other than those supplied with the device may result in measurement errors as other equipment e g transformers and cables may cause increased electromagnetic interference or have reduced electromagnetic immunity You should therefore only use genuine IEM accessories The cuff and the hose are made of a material that does...

Page 15: ...ectric 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 o High voltage power lines o Microwave devices Portable and mobile RF transmitters such as mobile phones for example may affect the blood pressure monitor Transmission of data via mobile communication networks may be disrupted by other device...

Page 16: ... pressure monitor the device must no longer be used If the blood pressure monitor is exposed to moisture switch the blood pressure monitor off and remove the batteries Immediately inform your healthcare provider physician Note This blood pressure monitor is intended for use in home healthcare environments and professional healthcare institutions such as first aid facilities and hospitals ...

Page 17: ...Description of device 17 DE EN 4 Description of device Blood pressure monitor Fig 1 Blood pressure monitor 1 Display 2 Infrared interface for service 3 Button 4 Battery cover 5 Air hose socket ...

Page 18: ...Description of device 18 Blood pressure cuff Fig 2 Blood pressure cuff 1 Blood pressure cuff 2 Air hose 3 Air hose connection ...

Page 19: ...Display 1 When this appears Battery empty 2 Display of systolic upper value 3 Data transfer 4 Bluetooth 5 Infrared communication 6 Number of pulse beats per minutes 7 Pulse detected 8 Number of measurement values 9 Display of diastolic lower value ...

Page 20: ...the condensation may damage it 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 a relative air humidity not condensing of 15 to 93 The blood pressure monitor takes approx 25 minutes to go from the minimum storage temperature of 25 C to th...

Page 21: ...are provider physician immediately 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 ...

Page 22: ...arries out a display test and displays the start screen see Fig 5 and Fig 6 Note Insert the batteries while holding the blood pressure monitor in your hand Take care not to activate the button on the front By pressing the button when inserting the batteries you will enter the pressure gauge mode used for servicing purposes Remove the batteries and insert the batteries again WARNING Make sure that ...

Page 23: ...g 5 Test screen Switching the blood pressure monitor on off Switching on Press the button The display shows the start screen Fig 6 Fig 6 Start screen Switching off The blood pressure monitor switches off automatically after about 5 minutes ...

Page 24: ... 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 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 blood ...

Page 25: ... 2 Fig 7 Insert air hose 1 Insert the air hose connection into the air hose 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...

Page 26: ...rectly against your skin 4 Insert your left arm into the blood pressure cuff Note Blood pressure cuffs are supplied preassembled If the cuff is not preassembled please assemble as follows Spread the cuff out with the Velcro fastening facing downwards One end 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 th...

Page 27: ...nger o The lower edge of the cuff must be about 2 cm 0 8 in above your elbow o The artery marking arrow above the hose must be pointing downwards on the middle of the inside of your arm 6 Once the blood pressure cuff is positioned correctly fasten the end with the Velcro Note Place the blood pressure cuff so that there is enough room to insert your index and middle fingers between the skin and the...

Page 28: ... 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 the same height as your heart 5 Relax your arm and turn the palm of your hand to face upwards 6 Place your feet flat on the floor and leave your legs uncrossed Note The reading can be affected by the position of the cuff the patient s correct posture and position physic...

Page 29: ...on again to start the measurement The blood pressure monitor will confirm this with a short acoustic signal and briefly displays the display functions The blood pressure cuff slowly pumps up The fitting pressure is displayed on the display After the initial pumping there is additional pumping Once the blood pressure monitor detects a pulse the icon appears The reading is taken as the air is let ou...

Page 30: ... 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 Stopping the measurement 1 If the measurement causes you pain press the button during the measurement The air is let out of the blood pr...

Page 31: ... data transfer please see section 12 Error messages If problems persist please contact your healthcare provider physician Note In the event of problems with data transfer if there are more than 350 readings 15 readings with PWA any new readings will overwrite the oldest readings Active Pairing Bluetooth Modem Note Pairing requires some basic familiarity with Bluetooth If you are not familiar with ...

Page 32: ...e After 3 seconds the display will show bt ignore this and hold down the button for another 3 seconds After 6 seconds the menu automatically opens and the display will automatically show the following menu items Passive pairing PAI P Infrared transmission Ir Active pairing PAI A Bluetooth transmission bt Delete measured values c lr 4 Wait until PAI A and the symbol are shown on the display 5 Press...

Page 33: ...Note Pairing requires some basic familiarity with Bluetooth If you are not familiar with Bluetooth please contact your healthcare provider physician 1 Wait until PAI P and the symbol are shown on the display 2 Press the button The passive pairing process will begin and PAI P and the symbols and will be shown on the blood pressure monitor display ...

Page 34: ... overwritten by the new readings Note If a PWA licence key is activated the storage capacity of the Tel O Graph BT is reduced from 350 to 15 measurements Only readings that have not yet been transferred to the database are saved ATTENTION Data loss To avoid data loss contact your healthcare provider physician before or when the display shows 350 measurements 15 readings with PWA The number of read...

Page 35: ...ssure monitor proceed as follows 1 Press and hold the button on the blood pressure monitor for about 6 seconds The display shows PAI P Fig 11 Delete measurements Note After every 3 s the display automatically shows the next menu item The sequence is Passive pairing PAI P Infrared transmission Ir Active pairing PAI A Bluetooth transmission bt Delete measured values c lr ...

Page 36: ...he display 3 Press the button You will hear an acoustic signal and the display will be shown c lr permanently 4 Press and hold the button for more than 3 seconds The acoustic signal sounds 3 times and the display shows M00 The measurements are deleted The device returns to standby mode and displays the start screen see Fig 6 ...

Page 37: ...components ATTENTION Do not immerse the cuff with balloon and blood pressure monitor in disinfectant water or other liquids If liquid nevertheless penetrates the device switch it off immediately and send it away to be checked by the manufacturer or healthcare provider physician Do not open the housing of the Tel O Graph BT otherwise any warranty becomes void Note Always observe the manufacturer s ...

Page 38: ...can leave behind residues and damage the material The cuff can be washed in the washing machine up to 30 C using a mild detergent without spin dry The cuff is not suitable for drying in a dryer The Velcro strip must always be closed before washing Cleaning the Tel O Graph BT To clean the blood pressure monitor use a damp cotton wool pad with a mild laundry detergent Do not use any other cleaning m...

Page 39: ...rpose 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 cuff hose and bladder are completely dry spread the cuff sleeve out with the Velcro fastening facing downwards Insert the bladder into the bladder compartment ...

Page 40: ...on Isopropanol 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...

Page 41: ...rofessionally 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 fur...

Page 42: ...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 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 ...

Page 43: ...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 possible that the blood pressure monitor is not suitable for you Contact your phy...

Page 44: ...er physician 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 blood pressure cuff with the air hose Err 9 Residual pressure in the blood pressure cuff Wait until the blood pressure cuff has deflated completely Err 10 Internal error If this error occurs repe...

Page 45: ... send readings Take another measurement and check whether the readings are transmitted If this error occurs repeatedly contact your healthcare provider physician Cod 4 Communication error If this error occurs repeatedly contact your healthcare provider physician Cod 5 Invalid target data in EEPROM memory If this error occurs repeatedly contact your healthcare provider physician Cod 6 Hardware comm...

Page 46: ...d Oscillometric Blood pressure measurement range Systolic 60 to 290 Diastolic 30 to 195 mmHg Pulse measurement range 30 to 240 1 min Pressure Accuracy 2 or 3 mmHg whichever is greater Memory without PWA 350 Measurements Memory with PWA 15 Measurements Power supply 4 6 VDC 4x NiMH or LR6 AA Dimensions L x W x H 151 X 108 X 57 Mm Weight without batteries 334 G Material housing ABS acrylonitrile buta...

Page 47: ...l 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 Symbols Symbol Meaning 4x NiMH or LR6 AA Manufacturer Date of manufacture YYYY MM DD Designation of the FCC radio authorisation ...

Page 48: ...ith the operating manual The symbol on the product or packaging means that this product should not be treated as normal domestic 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 electro...

Page 49: ...The following are excluded from the warranty All damage caused by improper handling e g as a result of failing to comply 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...

Page 50: ...ATTENTION Do not open the casing Once the device is opened all warranties will lapse Repairs If the device has functional errors please contact our customer service department who will also inform you about shipping procedures ...

Page 51: ...PR 11 Group 1 The Tel O Graph BT 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 is suitable for use in facilities other than residential areas and those directly connected to the public supp...

Page 52: ...f 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 or its cables than the recommended safe distance The field strength of stationary radio wireless transmitters should...

Page 53: ...l Compliance level Electromagnetic environment guidelines 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 ...

Page 54: ...0 390 MHz 27 V m PM 50 18 Hz 430 470 MHz 28 V m FM 5 kHz 1 kHz Sinus PM 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 704 787 MHz 9 V m PM 50 217 Hz 800 960 MHz 28 V m PM 50 18 Hz 800 960 MHz 28 V m PM 50 18 Hz 1700 1990 MHz 28 V m PM 50 217 Hz 1700 1990 MHz 28 V m PM 50 217 Hz 2400 2570 MHz 28 V m PM 50 217 Hz 2400 2570 MHz 28 V m PM 50 217 Hz 5100 5800 MHz...

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