manualshive.com logo in svg

MESI mTABLET ABI, Instructions For Use Manual, Page: 7 / 58

Share
Download
MESI mTABLET ABI Instructions For Use Manual Download Page 7

7

PRODUCT DESCRIPTION

PRODUCT
DESCRIPTION

2

The MESI mTABLET ABI diagnostic system package includes the 
following equipment:

• 

4x Tubeless Blood Pressure Cuff Module (including size M 

cuffs for the 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 tubeless 
cuff unit

Tubeless cuff - 
Medium 
(LA, RA, LL, RL)

Multifunctional LED button

Sliding lock

Tubeless cuff female 
connector

Power connector

Size indicator

Tubeless cuff male 
connector

Medial ankle 

Summary of Contents for mTABLET ABI

Page 1: ...Instructions for Use MESI mTABLET ABI Ankle Brachial Index ISO 9001 Q 1664 ISO 13485 M 049 MTABSYSABI...

Page 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...

Page 3: ...Instructions for Use ISO 9001 Q 1664 ISO 13485 M 049 MESI mTABLET ABI Ankle Brachial Index...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 57: ......

Page 58: ...09 2019 V 1 0...

Reviews:

No comments