MESI ABPI MD User manual

Instructions
for Use
MESI ABPI MD
Ankle-Brachial Index
ISO 9001 Q-1664
ISO 13485 M-049

CONTACT INFORMATION
Address MESI, development of medical devices, Ltd.
Leskoškova cesta 11a
SI-1000 Ljubljana
Slovenia, European Union
Telephone [phone]
E-mail [email protected]
Website www.mesimedical.com
DISTRIBUTOR INFORMATION

Instructions
for Use
ISO 9001 Q-1664
ISO 13485 M-049
MESI ABPI MD
Ankle-Brachial Index

CONTENT
1 SAFETY AND LEGAL RECOMMENDATIONS 6
1.1 LEGAL INFORMATION 6
1.2 SAFETY INFORMATION 6
1.2.1 Setup and technical personnel 6
1.2.2 Access to the device 6
1.2.3 Safety measures 6
2 PRODUCT DESCRIPTION 7
2.1 WHAT IS IN THE PACKAGE 7
2.1.1 Accessories 8
2.2 INTENDED USE 8
3 TECHNICAL SPECIFICATIONS 10
3.1 MESI ABPI MD 10
3.1.1 Dimensions 10
3.1.2 Power & battery 10
3.1.3 Cus 10
3.2 CLASSIFICATION 11
3.3 OPERATING, TRANSPORTING AND STORAGE CONDITIONS 11
3.4 MEASUREMENT SPECIFICATIONS 12
3.5 CONNECTIVITY 12
4 QUICK MEASURING GUIDE 13
4.1 PREPARATION FOR MEASUREMENT 14
4.1.1 Device placement 14
4.1.2 Air tubes 14
4.1.3 Patient preparation 14
4.1.4 Performing an ABI measurement 16
4.1.5 Performing a blood pressure measurement 17
4.2 RESULTS 18
4.2.1 Results of ABI measurement 18
4.2.2 Results of blood pressure measurement 19
5 DETAILED INSTRUCTIONS 20
5.1 FIRST TIME USE 20
5.1.1 Basic functionalities 20
5.1.2 AC/DC power supply and battery 20
5.1.3 Changing the device settings 22
5.2 PATIENT PROFILE 22
5.3 PERFORMING AN ABI MEASUREMENT 23

5.3.1 Cu placement 23
5.3.2 Performing the ABI measurement 27
5.4 REVIEWING AN ABI MEASUREMENT 29
5.4.1 Result screen 29
5.4.1.1 ABI values 29
5.4.1.2 Parameters 29
5.4.1.3 Waveforms 30
5.4.1.4 Comments 30
5.4.1.5 Adding patient 31
5.5 INTERPRETATION OF ABI RESULT 31
5.5.1 Detection of severe PAD and incompressible arteries 31
5.5.2 Pulse waveforms 32
5.5.3 Oscilation graph 32
6 MAINTENANCE 34
6.1 CHARGING THE BATTERY 34
6.2 CLEANING INSTRUCTIONS 34
6.3 DISINFECTION 35
6.4 PRODUCT LIFE AND STORAGE 36
7 GENERAL WARNINGS 36
7.1 PATIENT INJURIES PREVENTION 36
7.2 MEASUREMENT PROCEDURE 37
7.3 MAINTENANCE 38
7.4 FUNCTIONING OF THE DEVICE 39
8 ERRORS 40
9 TROUBLESHOOTING 41
10 WARRANTY INFORMATION 41
11 STANDARD COMPLIANCE 42
11.1 MANUFACTURER DECLARATION ON EMC 43
11.2 ESSENTIAL PERFORMANCE 48
12 IMPORTANT LABELS 49

All rights reserved. This publication may not be reproduced,
copied or stored on a memory device. Furthermore, this
publication may not be used for any purpose other than as the
instructions for the use of the MESI ABPI MD. This publication
may not be translated into other languages or converted into
other formats in any way without prior written permission of MESI
Ltd.
1.2 SAFETY INFORMATION
The contents of the instructions for use may be altered without
notice. The latest version of the instructions for use is available
at https://www.mesimedical.com/support/mesi-abpi-md/
instructions-for-use/.
To avoid personal injury and/or damaging the device or accessories,
follow the safety recommendations below.
SAFETY
AND LEGAL
RECOMMEN-
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 with
adequate professional training and experience who are aware
of all the dangers in relation to the setup of the device and its
use and who will take adequate risk prevention measures for
themselves, users, other personnel and devices.
Only authorised persons may be given access.
Local safety requirements are to be complied with if so required
by regulations. In addition to local safety regulations, the safety
instructions in this document are also to be complied with. In
case of any conflict between the safety recommendations in
this document and the recommendations stipulated by local
regulations, the local regulations take precedence.
The MESI ABPI MD users must be adequately trained to use the device. Before the first use of
the device, users must carefully read the entire instructions for use and follow the instructions for
use of the connected equipment.
6

7
PRODUCT DESCRIPTION
PRODUCT
DESCRIPTION
2
2.1 WHAT IS IN THE PACKAGE
The MESI ABPI MD (model name: ABPIMDD) is an automated
device intended for use in the professional environment. It
provides a fast, accurate and simple method for ABPI determina-
tion. The measurement can be performed with a 2-step (using 4
cus – one on each limb) or single step (using 3 cus – one cu
on the arm, the other two on the legs) process.
The MESI ABPI MD package includes the following equipment:
• MESI ABPI MD device,
• Set of 4 colour-coded blood pressure cus (size M),
• AC/DC adaptor,
• USB cable,
• Instructions for use,
• Calibration report and
• Declaration of conformity.

8PRODUCT DESCRIPTION
The MESI ABPI MD is an automated Ankle-Brachial Index (ABI)
measuring device for screening patients for Peripheral Arterial
Disease/Lower Extremity Arterial Disease (PAD/LEAD). The de-
vice is intended to perform, view and store ABI measurements of
adult patients in the PAD risk group.
The MESI ABPI MD is intended to be used solely in the profes-
sional clinical environment by trained healthcare personnel who
can correctly place blood pressure cus on the patient’s body,
verify that these cus are inflating or deflating normally, and start
the measurement process.
The MESI ABPI MD is intended to measure ABI by using a type
of plethysmography – the oscillometric method. The ABI result
(along with used blood pressure values used in calculating the
ABI), the pulse wave and the oscillation graph are captured and
displayed as numerical and graphical representations on the
device.
2.2 INTENDED USE
The MESI ABPI MD users must be adequately trained to use device.
Before the first use of the device, users must carefully read the entire
Instructions for Use and follow the Instructions for Use in full and follow
the Instructions for Use for any connected equipment.
ACCESSORIES
2.1.1 NOTE
Contact your local distributor for more information about dierent cu sizes
and other accessories.
Use only accessories and other parts recommended or supplied by
MESI. Use of any other than recommended or supplied parts may
result in injury, inaccurate measurements and/ or damage to the unit.
Follow the instructions provided with the specific accessory.

9
PRODUCT DESCRIPTION
The MESI ABPI MD supports automatic simultaneous ABI measurement of
systolic, diastolic and mean arterial blood pressure on the upper arm and ankle
locations to calculate the patients ABI. The device is recharged through the
AC/DC power supply.
The MESI ABPI MD device is not intended to be used during patient transport
and in emergency medical services.

10 TECHNICAL SPECIFICATIONS
DIMENSIONS
223 mm / 8.78 in
Width
Depth
174 mm / 6.85 in
86 mm / 3.38 in
Height
Weight 1000 g / 2.2 lbs
POWER &
BATTERY
Rechargable lithium-polymer battery
Battery type
Capacity 4400 mAh
> 100
Examinations per
battery charge
3.1 MESI ABPI MD
3.1.1
3.1.2
CUFFS
3.1.3 ABPIMDACFFBRM, ABPIMDACFFBLM,
ABPIMDACFFALM, ABPIMDACFFARM
Medium size cus
Circumference 22-32 cm
Large size cus ABPIMDACFFBRL, ABPIMDACFFBLL,
ABPIMDACFFALL, ABPIMDACFFARL
Circumference 32-42 cm
TECHNICAL
SPECIFICATI-
ONS
3Listed below is the technical information regarding the MESI ABPI
MD and its on-delivery specifications.
AC/DC adaptor FRIWO FW8030M/05 or FOX NEO30-XM
Input
Output
100-240 V AC / 50-60 Hz / 600-300 mA
5V DC / 3.0 A
Charge time for
depleted battery
2 hours
LEFT ARM yellow
RIGHT ANKLE black
LEFT ANKLE green
RIGHT ARM red

11
TECHNICAL SPECIFICATIONS
Class II
Protection against
electric shock
Medical device
classification
Class IIa
10° to 40°C ( 50° to 104°F)Temperature,
operating
Relative humidity 30 to 80% (no condensation)
Pressure during
operation
700 to 1060 hPa
If the device is used or stored outside the specified environmental parameters, the
accuracy specified within the technical specifications of the device is not guaranteed.
Applied parts (cus
for arms and ankles)
Type BF Applied part
Software classification Class A
RF emissions
(CIPSR 11)
Group 1. Class A
3.2 CLASSIFICATION
3.3 OPERATING, TRANSPORTING AND STORAGE CONDITIONS
Operating Conditions:
Ingress protection
rating
IP2X rating
0° to 40°C (32° to 104°F)Temperature
Relative humidity 15 to 85%
Pressure during
storage
700 to 1060 hPa
Transport & Storage Conditions:
Ingress protection
rating
IP2X rating

12 TECHNICAL SPECIFICATIONS
3.4 MEASUREMENT SPECIFICATIONS
Measurements using oscillometry and volume plethysmography:
• Ankle-Brachial Pressure Index
• Systolic blood pressure
• Diastolic blood pressure
• Mean average blood pressure
• Heart rate
Accuracy:
• Pressure: ± 3 mmHg
• Heart rate: ± 5% of value
• Ankle-Brachial Pressure Index: ± 0,1
Measurement range:
• Pressure: 0 to 299 mmHg
• Pulse rate: 30 to 199 beats per minute
The USB type C port is meant only for connecting the device to a PC
(via the USB cable enclosed in the packaging box) in order to transfer of
the measurement data.
The port is not meant to be used for connecting it with other USB type
C cables or chargers.
3.5 CONNECTIVITY

13
QUICK
MEASURING
GUIDE
4
NOTE
Before using the device for the first time, read the instructions for use
carefully and follow the recommendations and suggestions. This chapter only
includes short instructions for the use of the MESI ABPI MD. For a detailed
description of the individual functions of the device, see Chapter 5 DETAILED
INSTRUCTIONS.
NOTE
When performing the ABI measurement, the patient must be in a supine
position and remain still.
NOTE
The MESI ABPI MD is intended for use in the professional environment, where
the measurements are carried out by adequately trained medical personnel.
The MESI ABPI MD is not intended for home use.
NOTE
The MESI ABPI MD may be used on pregnant women.
NOTE
The MESI ABPI MD is not intended for use on new-borns or children under the
age of 10 years.
NOTE
In case of the presence of intravenous cannulas or arteriovenous (AV) fistulas,
the cus and measurement can cause injury to the limb.
The MESI ABPI MD has two modes of operation:
• The primary mode is for ABI measurement. The result of the
measurement is the left Ankle-Brachial Pressure Index (Left ABI),
the right Ankle-Brachial Pressure Index (Right ABI), blood pressure
in all limbs (SYS, DIA, MAP) and the heart rate.
• The additional mode is for the independent measurement of the
upper arm blood pressure. The result of the measurement is the
upper arm blood pressure (SYS, DIA, MAP) and the heart rate.
QUICK MEASURING GUIDE

14 QUICK MEASURING GUIDE
4.1 PREPARATION FOR MEASUREMENT
DEVICE
PLACEMENT
4.1.1 The operational environment of the device should be appropri-
ate to ensure accurate measurements. The main device must
be placed on a steady, horizontal surface. The device must not
be exposed to mechanical shocks and vibrations during opera-
tion. Such disturbances can significantly alter the measurement
results or even render them useless. For instance, placing the
device on a patient’s bed during the ABPI measurement cannot
provide reliable results.
The device must be operated within the +10°C to +40°C tempera-
ture range and 30% to 80% RH humidity.
MESI ABPI MD users must be adequately trained in use of the device.
Must carefully read and follow the entire Instructions for Use prior to
initial use of the device.
AIR TUBES
4.1.2
When the main device is adequately positioned, it can be connected
to the cus. The cus, the tubes and the sockets are colour-coded
to minimise the risk of improper connections.
The air tube connections are made by firmly inserting the plug into
the appropriate socket. Pull out the plug to disconnect the tube.
Hold the plug rather than the tube when disconnecting.
PATIENT
PREPARATION
4.1.3
The patient must be in a supine position, lie still and remain quiet. It is
recommended for the patient to lie still for at least 5 minutes before
starting the measurement process. During measurement, the patient
must lie completely flat, must be relaxed and must not talk. Their
legs must not be crossed. The operator selects between a 3-cu
and 4-cu measurement (when selecting the 3-cu measurement,
select the right or left arm).
NOTE
A considerate force is needed to insert or pull out the plug.
NOTE
When connecting the tubes, please make sure that the airflow is in not
obstructed in any kind of way.. For example, tube blockage can easily occur
by placing objects over it.

15
QUICK MEASURING GUIDE
Step 1 Choosing the right colour
Select the appropriate cu, depending on the description and the colour of the cu:
POSITION DESCRIPTION COLOUR
Right arm RIGHT ARM
on the cu of the cu
RED
Left arm LEFT ARM YELLOW
Right ankle RIGHT ANKLE BLACK
Left ankle LEFT ANKLE GREEN
Step 2 Place the cus to the appropriate arm/ankle
ARM:
• Position the cu 1-2 cm above the elbow joint. Align the ‘ARTERY’ label with the artery on
the inner side of the arm.
• Place the cu so that there is two fingers’ width of room between the limb and the cu.
• Make sure that you have chosen the correct size, using the INDEX marking and the OK
area of the cu.
ANKLE:
• Position the cu 2-3 cm above the ankle. Make sure that the ’MEDIAL ANKLE’ label points
towards the inner side of the ankle.
• Place the cu so that there is two fingers’ width of room between the limb and the cu.
• Make sure that you have chosen the correct size, using the INDEX marking and the OK
area on the cu.

16 QUICK MEASURING GUIDE
PERFORMING
AN ABI
MEASUREMENT
4.1.4
Amputation option: If a patient has an
amputated limb or is not compliant for ABI
measurement due to severe and/or painful
wounds, the ABI can be measured only
on the patient’s existing limbs. Before the
measurement, you can disable a selected
cu by clicking on the button and
selecting the limb that is not compliant for
the measurement.
Step 1
Observe the position indication on the
cus and place them on the appropriate
arm or leg.
Then press START (1) and wait until the
measurement is completed.
Step 2
1

17
QUICK MEASURING GUIDE
Depending on the right (1) or left (2) arm, select
and place the correct cu (red or yellow).
Step 1
PERFORMING
A BLOOD
PRESSURE
MEASUREMENT
4.1.5
Observe the position indication on the cu.
Then press START and wait until the measure-
ment is completed.
Step 2
1
2

18
4.2 RESULTS
On the top, the navigation menu provides the following actions:
– Repeat the measurement .
– Go to the Home screen.
NOTE
For more information about the result screen, see Chapter 5.4 Reviewing ABI
measurement.
Once the measurement is done, the system automatically switches
to the result page.
RESULTS OF ABI
MEASUREMENT
4.2.1
– Check the ABI results. For easier
interpretation the results are
colour-coded and a representative
scale is given as a reference.
– More detailed information is provided
(heart rate, SYS, DIA and MAP on the
arms and legs).
– Visual representation of the oscillation
and pulse waveform graphs.
– A comment can be added to every
measurement. It will be stored and
always available together with the
recording report.
– Optionally, the user may select an
existing or create a new patient. This
option is not required for a measure-
ment to be performed.
On the bottom the navigation menu provides the following actions:
– Go to the Archive.
QUICK MEASURING GUIDE

19
RESULTS OF
BLOOD PRESSURE
MEASUREMENT
4.2.2
On the top, the navigation menu provides the following actions:
– Check the blood pressure results.
For easier interpretation, the results
are colour-coded and a representative
scale is given for a reference.
– Visual representation of the oscilla-
tion and pulse waveform graphs.
– A comment can be added to every
measurement. It will be stored and
always available together with the
recording report.
– Optionally, the user may select an
existing or create a new patient. This
option is not required for a measure-
ment to be performed.
On the bottom, the navigation menu provides the following actions:
– Repeat the measurement.
– Go to the Home screen.
– Go to the Archive.
QUICK MEASURING GUIDE

20
DETAILED
INSTRUCTIONS
5This chapter contains all the information required by the users of
the device for safe, correct and accurate measurement. It includes
a detailed and complete description of all the functions of the
device, all safety instructions and all the information required to
understand the operation of the device.
5.1 FIRST TIME USE
BASIC
FUNCTIONALITIES
The MESI ABPI MD package includes MESI ABPI MD device, set
of colour-coded blood pressure cus (size M), AC/DC adaptor,
USB cable, instructions for use, calibration report and declaration
of conformity.
5.1.1
AC/DC ADAPTOR
AND BATTERY
The MESI ABPI MD uses the following two power sources:
• The mains electricity using AC/DC supply,
• Battery power.
Connect the AC/DC adapter into a wall power socket. Connect the
AC/DC adapter plug into the socket in the back side of the device.
5.1.2
Only use accessories and other parts recommended or supplied
by MESI. Use of any other parts may result in injury, inaccurate
measurements and/or damage to the unit. This product is not
designed for sterile use.
NOTE
The battery may not be completely discharged in a new device and it may
provide enough power to allow the device to start up. Nevertheless, the AC/
DC adapter must be connected when using the device for the first time.
The MESI ABPI MD can also function without the AC/DC power
supply. When the device is not connected to the mains electricity, it
is powered by a battery. The device is equipped with a high-capacity
Li-Po battery to ensure complete portability of the measurement
system. The battery is not replaceable.
DETAILED INSTRUCTIONS