Instructions for Use
MESI mTABLET ABI
Ankle-Brachial Index
ISO 9001
Q-1664
ISO 13485
M-049
MTABSYSABI
Страница 1: ...Instructions for Use MESI mTABLET ABI Ankle Brachial Index ISO 9001 Q 1664 ISO 13485 M 049 MTABSYSABI...
Страница 2: ...Address MESI development of medical devices Ltd Lesko kova cesta 11a SI 1000 Ljubljana Slovenia European Union Telephone 386 0 1 620 34 87 E mail info mesimedical com Website www mesimedical com DIST...
Страница 3: ...Instructions for Use ISO 9001 Q 1664 ISO 13485 M 049 MESI mTABLET ABI Ankle Brachial Index...
Страница 4: ...cation 10 3 1 5 Operating conditions 10 3 1 6 Measurement specifications 11 3 1 7 Connectivity 11 3 2 TUBELESS BLOOD PRESSURE CUFF MODULES 12 4 QUICK MEASURING GUIDE 13 4 1 PREPARATION FOR MEASUREMENT...
Страница 5: ...waveform 34 5 5 3 Oscilation graph 36 5 6 MULTIFUNCTIONAL BUTTON 37 5 6 1 LED indicators 38 5 6 2 Button functions 38 6 MAINTENANCE 39 6 1 CHARGING THE BATTERY 39 6 2 CLEANING INSTRUCTIONS 39 6 3 DISI...
Страница 6: ...DATIONS 1 SETUP AND TECHNICAL PERSONNEL 1 2 1 ACCESS TO THE DEVICE 1 2 2 SAFETY MEASURES 1 2 3 1 1 LEGAL INFORMATION SAFETY AND LEGAL RECOMMENDATIONS The device must be set up by authorised personnel...
Страница 7: ...left arm right arm left ankle and right ankle a wireless medical tablet system separate packaging and a 4 port charging station module separate packaging 2 1 WHAT IS IN THE PACKAGE Model CUFFMD MESI t...
Страница 8: ...ype of oscillometric method plethysmogra phy The Ankle Brachial Index result along with blood pressure values used in calculating the ABI pulse wave and oscillation graph are captured and displayed as...
Страница 9: ...9 PRODUCT DESCRIPTION The device is recharged through the AC DC power supply however the MESI mTABLET ABI is not intended to be used while connected to mains electricity...
Страница 10: ...I TUBELESS CUFF UNIT CUFFMD 3 1 1 3 1 2 3 1 4 CUFF SIZES 3 1 3 CUFF RAM CUFF LAM CUFF RLM CUFF LLM Medium size cuffs Circumference 22 32 cm Large size cuffs CUFF RAL CUFF LAL CUFF RLL CUFF LLL Circumf...
Страница 11: ...to 299mm Hg Heart rate 30 to 199 beats per minute Max deviation Pressure 3 mmHg Heart rate 5 of value Ankle Brachial Pressure Index 0 1 CONNECTIVITY 3 1 6 Data connectivity with MTABMD Bluetooth 2 1 E...
Страница 12: ...uff Modules medium size for automated wireless ankle brachial index measurement Provided tubeless cuffs Right arm red Left arm yellow Right ankle black Left ankle green NOTE For more information regar...
Страница 13: ...personnel The MESI mTABLET ABI is not intended for home use NOTE The MESI mTABLET ABI may be used on pregnant women NOTE The MESI mTABLET ABI is not intended for use on new borns or children under the...
Страница 14: ...fs are securely attached ASSEMBLY OF THE MESI TUBELESS CUFF UNIT 4 1 2 PATIENT PREPARATION 4 1 3 Patient needs to be in supine position lie still and remain quiet Step 1 Choosing the right colour of t...
Страница 15: ...the Artery on inner side of an arm Place the cuff so that there is two fingers width of room between the limb and the cuff Check that you have chosen the correct size using the INDEX marking and the...
Страница 16: ...UIDE 4 1 4 On the MESI mTABLET UNIT select an existing patient 1 or add a new one 2 Step 1 1 2 NOTE Observe instructions for use that are provided with the cuff After selecting the patient select the...
Страница 17: ...cuff or 4 cuff ABI measurement when selecting a 3 cuff measurement please select right or left arm and confirming These settings can be changed at any time by pressing Step 3 Observe the position ind...
Страница 18: ...esult screen see Chapter 5 4 REVIEWING ABI MEASUREMENTS DETAILED INSTRUCTIONS 5 This Chapter contains all the information required by users of the device for a safe correct and accurate measurement It...
Страница 19: ...ry state Otherwise see the chapter 6 1 CHARGING THE BATTERY for more information on battery charging 5 1 3 NOTE The battery inside a completely new device is most likely not completely empty and can p...
Страница 20: ...I TUBELESS CUFF UNIT the light on top of the module will change to green Confirm the pairing process by pressing the button on top of the module again Step 3 PAIRING 5 1 5 Before any measurements can...
Страница 21: ...It is possible to access all technical information about the connected modules in User profile Settings Modules Connected modules Step 4 NOTE While operating only with one MESI mTABLET UNIT performing...
Страница 22: ...SS CUFF UNIT firmly in your hands DETAILED INSTRUCTIONS ATTACHING THE CUFFS 5 1 6 Before first use cuffs should be disconnected from the MESI TUBELESS CUFF UNIT The conical cuff can be orientated any...
Страница 23: ...ation each conical cuff should be disconnected from the MESI TUBELESS CUFF UNIT To detach the cuff follow the next steps Push the sliding lock in the direction indicated on it and detach the conical c...
Страница 24: ...easurement patient needs to be selected or added to your working groups a patient list SELECTING A PATIENT 5 2 1 Select the patient tab button Step 1 Use the search bar 1 or scroll 2 to the patient wh...
Страница 25: ...e button On your home screen press the button in the Patient tab 5 3 PERFORMING AN ABI MEASUREMENT The patient must be in a supine position remain still and remain quiet NOTE It is recommended that th...
Страница 26: ...en using only 3 cuffs the user needs to identify the arm with the higher systolic blood pressure manually or perform the ABI measurement with both arms to obtain an accurate result NOTE Measurement of...
Страница 27: ...cuff on right leg Green cuff on left leg Black cuff on right leg Red cuff on right arm Green cuff on left leg Yellow cuff on left arm Option 1 ABI measurement with 3 cuffs right arm Option 1 ABI meas...
Страница 28: ...above the elbow joint Make sure that the arrow shaped artery marking is in line with the brachial artery Place the cuff so that there is two fingers width of room between the limb and the cuff Check...
Страница 29: ...inner side of the ankle Place the cuff so that there is two fingers width of room between the limb and the cuff Check that you have chosen the correct size using the SIZE marking and the OK area on t...
Страница 30: ...type of measurement 4 cuffs or 3 cuffs when selecting 3 cuffs you need to select the appropriate arm for calculating ABI left right Press OK Step 3 Amputation option if a patient has an amputated limb...
Страница 31: ...urrent pressure in the corresponding cuff Progress bar The progress bar shows the timeline of the ABI measurement When the bar comes to an end the measurement of all blood pressures concludes and all...
Страница 32: ...ion area Measurement parameters Oscillation graphs and Pulse waveforms Patient s ABI history Comment Navigation area Share for second opinion Discard result Go to Application screen Right and Left Ank...
Страница 33: ...r e mail addresses or by pressing the printer icon which will provide you with a printout of a selected measurement The navigation menu also contains the names of both the doctor performing the record...
Страница 34: ...he Abnormally weak pulse results describe the patients with an ABPI around or lower than 0 5 NOTE In case of Medial Calcinosis the arteries cannot be compressed due to stiff arterial walls The measure...
Страница 35: ...f a possible abnormality the measured ABI value is lower than the one with normal pulse waveform A flattened PVR waveform or a PVR without the typical shape is an indicator of severe PAD The absence o...
Страница 36: ...e also oscillation graphs which provide the operator with a pulse waveform analysis through the whole ABI measurement Below are a couple of examples of different oscillation graphs OSCILATION GRAPH 5...
Страница 37: ...s performed through the MESI mTABLET UNIT interface there is still a multifunctional button on top of the device Next to basic colour light notification functionalities of this button there is also a...
Страница 38: ...3 BUTTON FUNCTIONS Standby Quickly pressing the on button in standby mode will perform a basic status check of the MESI TUBELESS CUFF UNIT green more than 25 battery charge while red means less than...
Страница 39: ...ost likely spent and it should be replaced As the device does not contain any parts which can be replaced by a user contact your local distributor or the manufacturer about replacing the battery 6 1 C...
Страница 40: ...nse temperatures should not exceed 40 C NOTE Do not wash the cuffs in a washing machine or iron them NOTE The device must be calibrated in the event of mechanical stress 6 3 DISINFECTION Disinfection...
Страница 41: ...conditions for a maximum of 5 years While in storage the battery needs to be recharged once per three months to avoid accidentally over discharging the batteries When using the device after storage w...
Страница 42: ...If the patient has had breast surgery do not place the arm cuff on the side which has been operated on Do not use the device on a patient while they are connected to a vital sign monitor Check the pr...
Страница 43: ...e the device to malfunction which can potentially cause a dangerous situation The AC DC power supply must be connected to an easily accessible socket the AC DC power supply also serves for galvanic is...
Страница 44: ...cordance with Directive 2002 96 EC on scrap electrical and electronic equipment WEEE To prevent electric shock hazard due to leakage current only use AC DC power supplies which are compliant with the...
Страница 45: ...brachial calculation Repeat the measurement if the error is repeated the measured value is outside the measurement range of the device E6 Inflation error An error occurred during inflation of the cuf...
Страница 46: ...BELESS CUFF UNIT is not paired to the MESI mTABLET UNIT Pair the MESI TUBELESS CUFF UNIT to the MESI mTABLET UNIT For pairing see Chapter 5 1 5 Pairing N23 Replace battery High battery cycle Battery w...
Страница 47: ...state of the diagnostic module Press and hold the button on top of the MESI TUBELESS CUFF UNIT CUFFMD for 15 seconds to restart it No light indication when pressing the CUFFMD multifunctional button B...
Страница 48: ...electrical equipment Part 2 30 Particular requirements for the basic safety and essential performance of automated non invasive sphygmomanometers EN 1060 3 1997 A2 2009 Non invasive sphygmomanometers...
Страница 49: ...er of the above listed models should assure that they are used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The above listed mode...
Страница 50: ...ent coupling PORT Conducted RF induced by RF fields IEC 61000 4 6 a 3 Vrms 150 kHz 80 MHz 6 Vrms in ISM bands between 150 kHz 80 MHz c 80 AM 1kHz Comment Not applicable unit without Signal input outpu...
Страница 51: ...ess communications equipment IEC 61000 4 3 3 V m 80 MHz 2 7 GHz 80 AM 1 kHz Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment 27 V m...
Страница 52: ...4 0 MHz 5 3 MHz to 5 4 MHz 7 MHz to 7 3 MHz 10 1 MHz to 10 15 MHz 14 MHz to 14 2 MHz 18 07 MHz to 18 17 MHz 21 0 MHz to 21 4 MHz 24 89 MHz to 24 99 MHz 28 0 MHz to 29 7 MHz and 50 0 MHz to 54 0 MHz Ma...
Страница 53: ...re 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The amateur radio bands between 0 15 MHz and 80 MHz are 1 8 MHz to 2 0 MHz 3 5 MHz to 4 0 MHz 5 3...
Страница 54: ...should be less than 3 V m c The ISM industrial scientific and medical bands between 0 15 MHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 4...
Страница 55: ...MHz d 1 2 P 0 01 0 12 0 12 0 1 0 38 0 38 1 1 2 10 3 8 800 MHz to 2 5 GHz d 2 3 P Separation distance according to frequency of transmitter m 0 23 0 73 1 2 2 3 3 8 7 3 100 12 12 23 For transmitters rat...
Страница 56: ...damage to equipment TYPE BF APPLIED PART STANDARD COMPLIANCE IMPORATNT LABELS 11 2 ESSENTIAL PERFORMANCE MESI ABI MODULE is a part of MESI mTABLET ABI whose essential performance is performing an ABI...
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