boso 404180 100 PWV ABI System Instruction Manual

boso 404180 100 PWV ABI System

Specifications:

• Model: boso ABI-system 100 / boso ABI-system 100 PWV
• Measurement: Systolic and diastolic blood pressure on arm left, arm right, ankle left, ankle right
• Functions: Ankle Brachial Index (ABI) measurement for peripheral arterial disease detection
• Optional Function: Pulse Wave Velocity (PWV) measurement for arterial stiffness

Product Usage Instructions

1. Turning the Device On:
   Press the power button to turn on the device.

2. Installation and Operation of the Software:
   Connect the device to a computer using the provided USB cable. Install the Boso profile-manager XD software following the instructions provided.

3. Preparing for an ABI / PWV Measurement:
   Place the appropriate cuffs on the limbs to be measured – CA04 upper arm cuffs for arms and CL04 ankle cuffs for ankles. Ensure the cuffs are securely fastened.

4. Taking an ABI / PWV Measurement:
   Follow the on-screen instructions on the device or software to start the measurement process. The device will automatically calculate the Ankle Brachial Index (ABI) and optionally the Pulse Wave Velocity (PWV).

5. Cleaning and Disinfecting:
   After each use, clean the apparatus and cuffs using a mild disinfectant solution and a soft cloth. Ensure all parts are dry before storage.

FAQ:

• Q: What is the purpose of the boso ABI-system 100 / boso ABI-system 100 PWV?
  A: The purpose is the non-invasive measurement of systolic and diastolic blood pressure on specific limbs to detect peripheral arterial disease using the Ankle Brachial Index (ABI) and optionally measure Pulse Wave Velocity (PWV) for arterial stiffness.

• Q: How do I know which cuffs to use for measurements?
  A: Use CA04 upper arm cuffs for arm measurements and CL04 ankle cuffs for ankle measurements. The color codes (red for right arm, black for the right leg) on the cuff connections indicate the correct placement.

boso ABI-system 100 and boso ABI-system 100 PWV the powerful systems for the early detection of PAD and the determination of the pulse wave velocity (optional)

Contents of package

• 1 boso ABI-system 100 / boso ABI-system 100 PWV
• 2 CA04 upper arm cuffs
• 2 CL04 ankle cuffs
• 1 boso profile-manager XD
• 1 USB cable 3,0 m
• 1 boso power supply unit art. no.: 410-7-154
• 1 Warranty certificate
• 1 User instructions boso ABI-system 100 / boso ABI-system 100 PWV
• 1 User instructions boso profile-manager XD

Purpose

Non-invasive measurement of systolic and diastolic blood pressure on the following limbs: arm left, arm right, ankle left, ankle right. The thereby determined Ankle Brachial Index (ABI) is utilized as an indication of the prevalence of peripheral arterial disease.
In addition to the ABI measurement optionally via a second measurement, the pulse wave velocity (PWV) is determined. The PWV is an indicator of arterial stiffness. A stiff vessel expands less than an elastic vessel and therefore has a higher pulse wave velocity.

Contraindications

• For the oscillometric ABI measurement, the same exclusion criteria apply as for the doppler measurement.
• The device is not suitable for newborns and infants.
• Do not use the device in patients with severe heart failure.

Explanation of symbols and operating controls

• START key
  Press this key to start a measurement manually.
  All 4 cuffs will be inflated.

• STOP key
  Press this key to cancel an ABI measurement manually. All 4 cuffs will be deflated and the display switched off.

• The key for starting a single measurement
  These keys enable the user to start individual measurements of the limbs.

• Power on indicator
  The green light is illuminated when power is supplied to the device.
  To disconnect the instrument from the mains voltage, unplug the AC adapter from the wall socket.

Explanation of icons

• Read the user instructions
• Protection class II device
• Degree of protection against electric shock: type BF
• USB 2.0 connection
• The CE mark documents compliance with the Medical Devices Directive 93/42/EEC,
• Notified body: DEKRA, 0124.
• Manufacturer
• Year of manufacture
• Potential equalisation
• Do not dispose of this device in the domestic waste.
• For further information see page 13

Preliminary remarks
Your boso ABI-system 100 is an innovation on the market of blood pressure measurement technology for medical professionals. It provides a simple way of deter-mining the ankle-brachial index (ABI) and optional pulse wave velocity (PWV). The  pressure variations (oscillations) caused by pulse waves and transmitted by the cuffs are stored and evaluated by microprocessors. The great advantage of this type of measurement is that there is no need for a microphone or amplifier which must be positioned exactly if accurate results are to be obtained. This system complies with the European directives on which the German Medical Devices Act (CE mark: CE0124) is based and with European Standard EN 1060, Part 1: “Non-invasive sphygmomanometers – General requirements” and Part 3: “Supplementary requirements for electro-mechanical blood pressure measuring systems”. Calibration checks – every 2 years at the latest – can be performed either by the manufacturer, or the trade measurement authorities, or persons who fulfil the requirements of the legislation governing the operation of medical devices (German Medical Devices Operator Ordinance section 6). Instructions for calibration checks can be found on page 14 of these user instructions. Medical electrical apparatuses are subject to specific precautions as regards electro-magnetic compatibility and must therefore be installed and operated according to the EMC instructions given on page 15.

Important information

• The same exclusion criteria apply for oscillometric ABI measurements as for Doppler measurements.
• Cardiac arrhythmias can interfere with the accuracy of a measurement and produce incorrect readings. Interference can also occur in wearers of pacemakers if they have a weak pulse. The blood pressure monitor will have no effect on the pacemaker, however.
• The device is suitable for patients of all ages, whose upper arm circumferences are between 22 and 48 cm and ankle circumferences are between 18 and 38 cm.
• The device is not suitable for newborn babies.
• Do not use the apparatus in patients with severe heart failure.
• Do not use the apparatus unattended in unconscious, helpless or unresponsive persons.
• Do not place the cuffs over open wounds, implanted stents or lymphoedema.
• Allow at least 2 minutes between 2 consecutive measurements.
• Make sure that the tubes are not kinked during the measurement. A congestion could lead to injuries.
• During measurement, the flow of blood must not be stopped any longer than necessary (> 2 minutes). In case of a malfunction of the device, take off the cuffs from the arms and legs.
• Too many measurements may lead to impairment of blood flow and thus to injries.
• The cuff should not be applied on wounds, as this may cause further injuries.
• Make sure the cuff is not applied to an arm or leg which arteries or veins are or have been under medical treatment (e.g. shunt).
• Women with mastectomy should not have a cuff on the arm at the side where the breast has been amputated.
• During the measurement, a malfunction may occur in other medical devices that are applied simultaneously on the same arm.
• Operating the device in the vicinity of strong electromagnetic fields (e.g. radiation devices, mobile phones) can cause it to malfunction (see page 15).
• The computer used for the analysis must meet the requirements of EN 60601-1.
• If the instrument is to be sold, ensure that these user instructions are enclosed.
• The instrument has to be installed in a way that the plug of the power supply is easily accessible.

Ankle-Brachial Index (ABI)

To determine the ABI value, the systolic blood pressure values of the arms and legs must be measured. Blood pressure measurement values are given in mmHg (mm of mercury).
The ABI is calculated as a quotient of the systolic pressure of the leg measurement
(the mean pressure of the posterior and anterior tibial arteries) and the higher systolic pressure of the arm measurements.

Pulse wave velocity (PWV) (optional)
The pulse wave velocity is calculated using the pulse transit time between upper arm and ankle, and body size. The measured values are given in m / s (meters per second).

Turning the device on

The main connection socket is located at the rear of the device.
Use only the boso power supply unit (order no. 410-7-154), as it produces a rectified output of the correct polarity. Other commercially available power supply units can cause damage to the electronic components, which will invalidate the warranty.
To establish the potential equalization connect an appropriate wire to the relevant potential compensation of the unit. Furthermore, the requirements of EN 60601- 1:2006 applies for potential compensation.

WARNING
The bonding conductor shall not be used as a protective conductor connection.

Installation and operation of the software of the ABI-system 100 see user instruction/installation guide of boso profil-manager XD
Preparing for an ABI / PWV (optional) measurement

WARNING
The measurement must be performed with the patient supine to ensure comparable blood pressure conditions in arms and legs. The legs must not be crossed.

The patient should rest for about 5 minutes before a measurement is taken.
Attaching the cuff
WARNING
The device should only be used with original boso CA04, CA03, CA02 or CL04 cuffs.

• The cuffs are colour-coded. Attach the individual cuffs to both upper arms and both ankles according to their colour coding (matching the symbols next to the air connection sockets on the apparatus).
• Attach the upper arm cuffs so that the lower edge of the cuff is about 2-3 cm above the elbow joint.
• The cuff should be positioned in such a way that the marking is over the brachial artery.

WARNING
Never place the metal ring over arteries, as this may produce an incorrect reading.

• Attach the ankle cuffs so that the lower edge of the cuff is about 1-2 cm above the ankle joint.
• The cuff should be positioned in such a way that the white marking is over the posterior tibial artery.
• Ensure that the cuff fits tightly at the ankle.

Assignment of cuffs to limbs.
Check that the cuffs are correctly assigned to the individual limbs by individual measurements of the right or left arm and right or left leg.

Taking an ABI / PWV (optional) measurement

• A measurement can be canceled at any time by clicking on the “Cancel measurement” button in the software or pressing the STOP key on the apparatus; all the cuffs deflate automatically. Alternatively, the cuffs can be removed from the limbs at any time. Select “Start new measurement” in the “Measurements” tab or press the START button on the apparatus. The ABI-system 100 starts the ABI measurement after a short calibration process (about 3 seconds).

• The apparatus has an intelligent automatic inflation system to ensure comfortable inflation to the correct cuff pressure. When the correct inflation pressure has been reached, the pump will switch off and the cuffs will deflate automatically.

At this point (if not before) the patient must keep all four limbs completely still and may not talk. (optional)

• Select “ABI + PWV measurement” in the registry “data” or press the START button on the unit. The ABI-system 100 starts the ABI measurement after a short calibration procedure (about 3 seconds). Upon completion of the ABI measurement and another break (about 10 seconds), the PWV measurement is started.
• After the measurement, the valves are opened automatically to allow rapid deflation of the cuffs. The measured values are displayed in the profilmanager XD.

Individual comments can be added for each ABI measurement via the “Remarks…” button. Templates can be defined and stored for later usage.

Saving an ABI / PWV (optional) measurement
To save an ABI measurement, select “Save measurement”.

The measurement must be repeated if the results are wrong Blood pressure is a dynamic parameter and can be influenced by various effects:

• movement before or during the measurement
• physical condition (stress, illness …)

Repeating an ABI / PWV (optional) measurement

• Allow an interval or at least 2 minutes between successive measurements.
• To repeat an ABI measurement select “ABI measurement” or “ABI + PWV measurement”.
• To measure one limb only, press the START key next to the corresponding symbol.
• When determining the ABI it is recommended to perform all measurements at the same time.
• If no further measurement is required, remove the cuffs from the limbs.

Cleaning the apparatus and cuff

• Please use only a soft, dry cloth to clean the device.
• Small stains on the cuff can be carefully removed with a damp cloth.

Disinfecting the apparatus

• We recommend Antifect® Liquid disinfectant (Schülke&Mayr) to wipe the apparatus and cuffs for disinfection. To disinfect the cuff, we recommend spray disinfection.

Warranty and customer service

• We give 2 years warranty from the date of purchase. The purchase date has to be proven by the invoice. Within the warranty period, defects are eliminated free of charge. After repairs the warranty period is not extended on the whole unit, but only to the replaced components.
• Excluded from the warranty are parts subject to normal wear and tear (e.g. cuff), transport damages and any damage caused by improper handling (e.g. non-com-pliance with the instructions for use). Damages due to disassembly by unauthorized persons are also excluded from the warranty.
• No claims for damages against us are substantiated by the warranty. In the case of justified warranty claims the device has to be sent along with the original invoice to:
  • BOSCH + SOHN GMBH U. CO. KG Bahnhofstr. 64
  • D-72417 Jungingen

WARNING

• This device must be maintained by trained and approved staff.
• Do not modify this equipment without the authorization of the manufacturer.

Technical data

• Measurement principle: oscillometric

• Measurement range: 60 to 240 mmHg (blood pressure, SYS)

• Measurement range: 40 to 140 mmHg (blood pressure, DIA)

• Cuff pressure: 0 to 300 mmHg

• Maximum deviation of cuff pressure measurement:± 3 mmHg  (max. difference right/left ± 2 mmHg)

• Measurement range puls: 30 to 190 puls/min.

• Maximum deviation puls measurement: of ± 5 %

• Maximum deviation of ± 5 %

• PWV measurement:

• Operating conditions: Environmental temperature +10 to +40°C

• Relative humidity 30 to 85%

• Transport and storage conditions: Environmental temperature -10 to +60°C

• Relative humidity 30 to 85%

• Power supply: DC 5 V power supply unit, 2.7 A, AC 100-

• 240 V, 50-60 Hz, order no.: 410-7-154

• Weight: 3.7 kg without power supply unit

• Dimensions (W x H x D): 460 mm x 83 mm x 290 m

• Classification: Protection class II (Symbol )
  Type BF (Symbol : )

• Clinical test (DIN 58130): accuracy complies with the requirements of EN 1060 part 3

Subject to technical modifications

Instructions for disposal

This apparatus falls within the scope of EC Directive 2002/96/EC (WEEE). It is not registered for use in private households and disposal via communal collection sites for obsolete electrical apparatus is prohibited. Bosch + Sohn has commissioned a company to dispose of the apparatus safely and legally. Please refer to the address mentioned at the end of these user instructions for further information.

Calibration checks – Testing instructions

Function testing
Function testing of the device can only be carried out on a person or with a suitable simulator.

Testing of pressure circuit integrity and deviation of pressure display

1. Use the “Pressure sensors A” or “Pressure sensors B” button in the sub-registry “Test mode” to start the test mode.
2. After a short calibration process, the apparatus will be in test mode. The current pressure will be displayed in the corresponding boso profile-manager XD fields.
3. Perform the usual test for deviation of pressure display and pressure circuit integrity (allow a set-up time of at least 30 seconds for the cuff). Maximum difference of the pressure right – left ± 2 mmHg.
4. Run the test for all 4 limbs.
5. Exit test by pressing the “Finish test” button.
   WARNING The activation of the “pressure sensors B” is only possible for devices with serial numbers upper 46620000 and upper 47300000.

Safety seal
As a safeguard, the upper and lower parts of the housing can be joined with a safety seal. The unauthorized destruction of the hedging mark voids the warranty. (optional)
The testing of the “PWV”-function requires specialized simulators and can just be done by the manufacturer.

EMC notes for boso ABI-system 100 / boso ABI-system 100 PWV

Guidance and manufacturer’s declaration – electromagnetic emissions

The boso ABI-system 100 (PWV) is intended for use in the electromagnetic environment specified below. The customer of the user of the boso ABI-system 100 (PWV) should assure that it is used in such an environment.
Aussendungs- Messungen| Übereinstimmung| Elektromagnetische Umgebung-Leitlinien
RF emissions CISPR 11| Group 1| The boso ABI-system 100 (PWV) uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interfe- rence in nearby electronic equipment.
RF emissions

CISPR 11

| Class B| The boso ABI-system 100 (PWV) is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions

IEC 61000-3-2

| Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3| Complies
Guidance and manufacturer’s declaration – electromagnetic immunity

The boso ABI-system 100 (PWV) is intended for use in the electromagnetic environment specified below. The customer or the user of the boso ABI-system 100 (PWV) should assure that it is used in such an environment.

Immunity test

| ****

IEC 60601-

test level

| ****

Compliance level

| ****

Electromanetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2| ± 8 kV

contact

± 15 kV

| ± 8 kV

contact

± 15 kV

| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
 | air| air|
Electrical fast transi- ent/burst IEC 61000-

4-4 (100kHz)

| ± 2 kV

power supply lines

± 1 kV

| ± 2 kV

power supply lines

± 1 kV

| Mains power quality should be that of a typical commercial or hospital environment.
 | input/output lines| input/output lines|
Surges IEC 61000-

4-5

| ± 1 kV

differential mode

| ± 1 kV

differential mode

| Mains power quality should be that of a typical commercial or hospital environment.
 | ± 2 kV| ± 2 kV|
 | common mode| common mode|
Voltage dips, short| Test level – % Uref| Duration s / Phase °| Mains power quality should be that of a typical commercial or
interruptions and

voltage variations on power supply input lines IEC 61000-4-11

| A/A 30

A/A 100

| 0.50 (0)

0.01 (0, 45, 90,

135, 180, 225, 270,

| hospital environment. If the user of the boso ABI-system 100 (PWV) requires continued operation during power mains interrup-

tions, it is recommended that the boso ABI-system 100 (PWV) has to be powered from a uninterruptible power supply or a battery.

 |  | 315)|
 | A/A 100| 0.02 (0)|
 | C/C 100| 5.00 (0)|
Power frequency (50/60Hz) magnetic field IEC 61000-4-8| 30A/m| 30A/m|
Guidance and manufacturer’s declaration – electromagnetic immunity

The boso ABI-system 100 (PWV) is intended for use in the electromagnetic environment specified below. The customer or the user of the boso unit should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
 |  |  | Portable and mobile RF communications equipment should be used no closer to any party of the boso ABI-system 100 (PWV), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

Conducted IEC 61000-4-6| 3 V rms /m

ISM: 0,15 MHz bis

| 3 V rms /m

ISM: 0,15 MHz bis

| d = 1,2 ÖP
and ISM & radio| 80MHz| 80MHz|
band| radio band:| radio band:|
 | 0,15 MHz bis| 0,15 MHz bis|
(6V rms)| 80 MHZ| 80 MHZ|
Spot-frequency: 380 MHz bis 5800MHz| 6Vrms /m| 6Vrms/m| d = 1,2 ÖP
Radiated RF IEC 61000-4-3| 3Vrms /m

150kHz bis 80MHz

| 3Vrms/m

150kHz bis 80MHz

| d = 1,2 ÖP 80 MHz to 800 MHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts,s and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the boso unit is used exceeds the applicable RF compliance level above, the boso unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the boso ABI- system 100 (PWV).
Recommended separation distances between portable and mobile RF communications equipment and the boso ABI-system 100 (PWV)

The boso ABI-system 100 (PWV) is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the boso ABI-system 100 (PWV) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the boso ABI-system 100 (PWV) as recommended below, according the the maximum output power of the communications equipment.
Rated maximum| Separation distance according to frequency of transmitter
output| m
power of trans-

mitter

| 150 kHz bis 80 Mhz

d= 1,2 ÖP

| 80 Mhz bis 800 MHz

d= 1,2 ÖP

| 800 Mhz bis 2,5GHz d= 2,3 ÖP
W|  |  |
0,01| 0,12| 0,12| 0,23
0,1| 0,38| 0,38| 0,73
1| 1,2| 1,2| 2,3
10| 3,8| 3,8| 7,3
100| 12| 12| 23
For a transmitter rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

BOSCH + SOHN GmbH u. Co. KG
Bahnhofstrasse 64 • 72417 Jungingen • Germany Phone: +49 (0) 74 77 / 92 75-0 • Fax: +49 (0) 74 77 / 10 21 www.boso.de • mail: [email protected]
Subject to change without prior notification. Omissions and errors excepted. (10/01/2018)

References

• Gesundheit ist Vertrauenssache. blutdruckmessen ist boso. - boso

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