br102 Plus
br102 Plus
br102 Plus
User Guide
Sales and Service Information
The SCHILLER sales and service centre network is world-wide. For the
address of your local distributor, contact your nearest SCHILLER
subsidiary. In case of difficulty a complete list of all distributors and
subsidiaries is provided on our internet site:
www.schiller.ch
Address Headquarters
SCHILLER AG Tel: +41 (0) 41 766 42 42
Altgasse 68 Fax: +41 (0) 41 761 08 80
CH-6341 Baar sales@schiller.ch
Switzerland www.schiller.ch
BR-102 plus / BR-102 plus PWA bears the CE-0123 mark (Notified Body TÜV-SÜD Produkte Ser-
vice GmbH, Ridlerstr. 65, 80339 Munich, Germany), indicating its compliance with the essential re-
quirements of the Annex I of the Medical Device Directive 93/42/EE regarding safety, functionality
and labelling. The requirements apply to patients, users and third persons who come into contact
with this device within the scope of its intended use.
Contents
2 Introduction ............................................ 13
2.1 BR-102 plus / BR-102 plus PWA ............................... 14
2.1.1 BR-102plus........................................................................... 14
2.1.2 BR-102 plus PWA................................................................. 14
2.2 The medilog®DARWIN2 Program ............................. 15
2.3 Inserting/Changing the Batteries.............................. 15
2.4 Connecting the Pressure Hose and Microphone .... 16
2.5 Main Components of the Device............................... 17
2.5.1 Operating and Display Elements .......................................... 18
2.5.2 Switching on ......................................................................... 18
2.5.3 Switching Off ........................................................................ 19
2.5.4 Battery Status for NiMH Rechargeable Batteries ................. 20
2.5.5 Battery Display for Energizer Ultimate Lithium Battery......... 21
2.5.6 Time Display......................................................................... 21
2.6 Menu Structure........................................................... 22
2.6.1 Menu Overview..................................................................... 23
Art. no.: 2.511076 Rev.: g
3 BP recording ........................................... 26
3.1 Safety .......................................................................... 26
3.2 Applying the Cuff ....................................................... 28
3.2.1 Cuff Type with D-ring ............................................................ 30
3.2.2 Cuff Type without D-ring ....................................................... 30
3.2.3 Patient Comfort Sleeve......................................................... 31
3.2.4 Fixing the Microphone Directly on the Upper Arm ................ 31
3.2.5 Securing the Cuff with the Fixation Pad ............................... 32
3.3 Single Measurement .................................................. 33
3.4 Long Term Recording................................................ 34
3.4.1 RECORD SETUP ................................................................. 35
Page 3
BR-102 plus / BR-102 plus PWA
5 Cleaning ...................................................44
5.1 Important Information ............................................... 44
5.1.1 Non-admissible detergents ................................................... 44
5.1.2 Admissible detergents .......................................................... 45
5.1.3 Cleaning the Device.............................................................. 45
5.1.4 Cleaning the Pressure Hose/Microphone Cable Assembly .. 45
5.2 Cleaning the Cuff and Pouch.................................... 46
5.2.1 Cleaning the Cuff .................................................................. 46
5.2.2 Cuff Preparation.................................................................... 47
5.2.3 Cleaning the Pouch (as well as the Shoulder and Waist strap) 50
5.2.4 Disinfection ........................................................................... 51
5.2.5 Admissible Disinfectants for the Casing ............................... 52
5.2.6 Non-admissible disinfectants ................................................ 52
5.2.7 Sterilisation ........................................................................... 52
6 Maintenance ............................................53
6.1 Visual Inspection ....................................................... 53
6.2 Battery Maintenance.................................................. 54
6.2.1 Charging the Batteries .......................................................... 54
6.2.2 Battery Disposal.................................................................... 54
6.3 Calibration .................................................................. 55
6.4 Measurement Check.................................................. 55
6.4.1 Equipment Required ............................................................. 55
Art. no.: 2.511076 Rev.: g
8 Accessories .............................................63
8.1 Documentation........................................................... 63
Page 4
BR-102 plus / BR-102 plus PWA User Guide
11 Index ........................................................ 71
Page 5
BR-102 plus / BR-102 plus PWA
Page 6
Safety Notes 1
BR-102 plus / BR-102 plus PWA User Guide User Profile 1.1
1 Safety Notes
1.1 User Profile
Medical Personnel (Operator, User)
This blood pressure recorder as well as the analysis program are
provided for the exclusive use of qualified physicians or trained
medical personnel under their direct supervision.
Page 7
1 Safety Notes
1.3 Contraindications BR-102 plus / BR-102 plus PWA
1.3 Contraindications
The BR-102 plus / BR-102 plus PWA has not been designed for,
and must not be used for the following patients:
– neonates and children under the age of 3.
– Patients who must undergo invasive blood pressure monitoring.
Page 8
Safety Notes 1
BR-102 plus / BR-102 plus PWA User Guide Maintenance 1.6
1.6 Maintenance
There are no serviceable parts inside. Refer servicing to qualified
technician authorised by SCHILLER only.
Do not use high temperature sterilisation processes (such as
autoclaving). Do not use E-beam or gamma radiation sterilisation.
Do not use solvent or abrasive cleaners on either the unit or cable
assemblies.
Do not, under any circumstances, immerse the device or cable
assemblies in liquid.
1.7 Hygiene
For cleaning and disinfection observe the legal requirements
applicable.
Only use cleaning agents and disinfectants recommended by
SCHILLER. Unsuitable agents can damage the device. Clean and
disinfect the device in accordance with the instructions given in
this book.
Page 9
1 Safety Notes
1.10 Operation with other Devices BR-102 plus / BR-102 plus PWA
Page 10
Safety Notes 1
BR-102 plus / BR-102 plus PWA User Guide Safety Symbols and Pictograms 1.11
Page 11
1 Safety Notes
1.11 Safety Symbols and Pictograms BR-102 plus / BR-102 plus PWA
IP42 According DIN VDE 0470 PART 1 /EN 60529 / IEC 529
(with carrying pouch) Protection against deposits of dust and protection against spray
water. (The first digit indicates the protection of the equipment against
ingress of solid foreign bodies and dust and the second digit indicates
the degree of protection of the equipment inside the enclosure from
ingress of water).
• Dry Clean
• Wash the pouch at a temperature of 30° C and the cuff at 40°C.
• Select gentle or delicate cycle.
Page 12
Introduction 2
BR-102 plus / BR-102 plus PWA User Guide Safety Symbols and Pictograms 1.11
2 Introduction
The SCHILLER BR-102 plus / BR-102 plus PWA is an Ambulatory
Blood Pressure Recorder used for single and long-term recordings.
The device can take up to 100 measurements over a 24 hour
recording period, and up to 200 measurements over a 48 hour
recording period. All recorded data is stored in an internal memory
and can be uploaded to the medilogDARWIN2 program. The recorder
has four recording programs that can be defined by the user with
individual time and interval settings for each program. This enables
long-term blood pressure measurements to be taken at pre-set
intervals for different patients and conditions.
Standard
• BR-102 plus Ambulatory Blood Pressure recorder Standard, or BR-
102 plus PWA (Pulse Wave Analysis)
• Four rechargeable AA NiMH batteries
• Battery charger unit
• Cuff size ‘M’ (medium) adult, and pressure hose with microphone
• Comfort Sleeve size ‘M’ (medium) adult
• Securing pouch with shoulder and waist-strap
• medilogDARWIN2 software
• USB cable
• BR-102 plus / BR-102 plus PWA user guide
Cuffs and Accessories
Cuffs are available in sizes ‘XS’ (extra small, Osc. only), ‘S’ (small), ‘M’
(medium), ‘L’ (large), and ‘XL’ (extra large). A list of these and other
accessories are given at the end of this book (see Accessories, page
63)
Art. no.: 2.511076 Rev.: g
Page 13
2 Introduction
2.1 BR-102 plus / BR-102 plus PWA BR-102 plus / BR-102 plus PWA
2.1.1 BR-102plus
To obtain the extra data needed for PWA, the measurement cycle
differs from standard BP measurement. After every individual
measurement (and the SYS and DIA values recorded), the cuff is
again inflated to the diastolic pressure. This pressure is then held for
10 seconds while the PWA data is obtained. After 10 seconds the cuff
Art. no.: 2.511076 Rev.: g
An outline of PWA principal is given at the end of this book (see BR-
102 plus PWA, page 65).
Page 14
Introduction 2
BR-102 plus / BR-102 plus PWA User Guide The medilog®DARWIN2 Program 2.2
positive
Page 15
2 Introduction
2.4 Connecting the Pressure Hose and Microphone BR-102 plus / BR-102 plus PWA
Position the pressure hose connector (a) and attach to the BR-102
plus / BR-102 plus PWA by gently pressing until the connector clicks
in place. If the version is with a microphone (c), the plug is combined
with the hose and the assembly is inserted into BR-102 plus / BR-102
plus PWA at the same time.
c Removing the Pressure Hose
a
b Gently press the securing catch (b) to release and remove the hose
connector (and microphone jack plug) from the BR-102 plus / BR-102
plus PWA.
Two hoses are compatible with the BR-102 plus: see Cuff and Cuff
Accessories, page 64.
Art. no.: 2.511076 Rev.: g
Page 16
Introduction 2
BR-102 plus / BR-102 plus PWA User Guide Main Components of the Device 2.5
05:16PM
NEW RECORD
LAST RECORD
SINGLE MEAS.
SYSTEM
NEXT OK
SCHILLER
BR-102plus
l k j i h g f
(a) USB cable connection
(b) OLED display
(c) Loudspeaker
(d) Microphone connector jack plug and patient cuff connection re-
cess
(e) USB connector
(f) Battery recess (battery cover removed)
(g) Battery removal ribbon
Art. no.: 2.511076 Rev.: g
The micro SD memory card is for service only and is used for software
updates or storage of raw data for test purposes.
Page 17
2 Introduction
2.5 Main Components of the Device BR-102 plus / BR-102 plus PWA
Holding the key stops the recording Start: Starts the acoustic
record of the patient ID
Break: Halts an ongoing
measurement SCHILLER Stop: Stops a recording in
BR-102plus
progress
Stop: Stops a recording in progress
2.5.2 Switching on
Press the green ON/OFF key. The display shows an introduction
screen and copyright message for a few seconds and then the main
menu is displayed. If an unformatted micro SD card is installed, you
are prompted to format the card when the recorder is switched on, and
again when a recording is started.
Art. no.: 2.511076 Rev.: g
Page 18
Introduction 2
BR-102 plus / BR-102 plus PWA User Guide Main Components of the Device 2.5
05:16PM
15.12.2013
NEW RECORD
LAST RECORD
SCHILLER
SINGLE MEAS. BR-102plus
SYSTEM
. . exit
NEXT OK
SCHILLER
If a recording is running, first stop the recording by holding the Green
control button for 4 seconds and confirming that the recording will
be stopped (see Stopping the Recording, page 39). Then enter the
main menu and switch off as described above. Any recorded data is
saved when the recorder is switched off.
Page 19
2 Introduction
2.5 Main Components of the Device BR-102 plus / BR-102 plus PWA
Full The battery symbol in the upper right of the screen, indicates the
80% battery status. When the battery is full, the symbol is filled and gives
an indication of current battery capacity as it reduces during the
Half full recording. The empty symbol indicates that the capacity is limited and
Low capacity (20%) that the batteries should be changed. If the batteries are not changed
Empty during this period, a warning message is given that the batteries must
be changed. If the batteries are still not changed an error message is
displayed before the recorder switches off (see next page).
WARNING ERROR
NO YES OK
Battery Condition
Batteries deteriorate over time and must be replaced. An indication of
battery condition is given when batteries are first placed in the
recorder after a full charge, as follows:
Page 20
Introduction 2
BR-102 plus / BR-102 plus PWA User Guide Main Components of the Device 2.5
Page 21
2 Introduction
2.6 Menu Structure BR-102 plus / BR-102 plus PWA
The position in the menu is indicated on the top line as shown in the
example above for new record. Select the item with the green button
and confirm with the blue key.
In all displays, the top line is colour coded to give an indication of the
type of message that is displayed as follows:
Page 22
Introduction 2
BR-102 plus / BR-102 plus PWA User Guide Menu Structure 2.6
Defines the
NEW RECORD Patient Adult / Child - Maximum initial pressure for adult is
recording
RECORD SETUP Group 300mmHg and for a child 210mmHg.
parameters
Record
24/48 Hours
Duration
Defines the
Select
program Select one of four individual recording programs A, B, C,
PROGRAM program
parameters D. The programs are defined in Program Setup below.
A, B, C, D
Change / Next
1.Define the start time by press-
ing change. The time counts
up in 10 minute intervals.
2.When the desired start time is
A, B, C, D - Four shown press next. The
individual BP measurement interval is
measurement pro- highlighted.
grams (A, B, C
3.Press change to select a BP
and D) can be de-
PRO-
fined. Each indi-
measurement interval of: 5, 10,
GRAM 15, 20, 30, 60, or 120 minutes.
vidual program
Art. no.: 2.511076 Rev.: g
Record
PATIENT ID Start Start Voice Recording.
Voice
Page 23
2 Introduction
2.6 Menu Structure BR-102 plus / BR-102 plus PWA
Plays recorded
Play Voice patient identifica- Stop Stop Playing Voice.
tion.
Yes / No - Confirm
Press either of the two
Recording start.
function keys for approx-
imately a second to take
Confirmation of
an extra measurement
Do you recording start is BP re-
during the recording.
want to given, followed by cording .
START start a BP REC: BP record- Next
Press either of the two
Record- ing and the time of Meas. ..
function keys when a
ing? the next measure- 09.15
measurement is being
ment (this is dis-
taken to interrupt a
played for approx-
measurement being tak-
imately 5
en during the recording.
seconds).
SINGLE
PATIENT
MEAS- Adult / Child - Maximum initial pressure for adult is 300mmHg and for a child 210mmHg.
GROUP
UREMENT
DEFLA-
TION 2, 3, 4, 5, 6, 7, 8, 9 mmHg/s or Auto (3mmHg / heart beat).
SPEED
Page 24
Introduction 2
BR-102 plus / BR-102 plus PWA User Guide Menu Structure 2.6
OK
Measurement is displayed (or an error message is given).
Measurement
Press OK again to return to the previous menu.
START starts and value
BREAK
displayed.
Interrupt measurement: Press the break button when a measure-
ment is being taken to interrupt the measurement.
SYSTEM SETTINGS Language ENG, DEU, FRA, ITA, SPA, POR, SWE, RUS.
DATE / • DD.MM.YYYY
TIME • MM/DD/YYYY
• yyyymmmdd
Date Set current date in the
• ddmmmyyyy Set date
Format format defined.
• YYYY-MM-
DD
• YYYYMMDD
SYSTEM Serial number, Hardware and pneumatic index, software version, control (date that the
INFO next test (MTK) is due), SD card capacity (if inserted)
Return to main
BACK
menu.
Art. no.: 2.511076 Rev.: g
Page 25
3 BP recording
3.1 Safety BR-102 plus / BR-102 plus PWA
3 BP recording
3.1 Safety
Danger of unnoticed necrosis especially in patients with
decreased pain sensitivity (due to medication), or with older
patients with decreased blood circulation of the extremities. Only
carry out long-term measurement with these patients under
constant medical supervision.
Possibility of strangulation especially in young or older patients,
patients with reduced mobility, or patients susceptible to
drowsiness due to drugs, etc. The danger increases at night. Only
carry out long-term measurement with these patients under
constant medical supervision.
In some patients petechiae, haemorrhages or subcutaneous
haematomas may occur. All patients must be told when putting on
the cuff that if they experience pain during the recording they
should switch off the equipment and inform the doctor.
The cuff must not be attached to a limb that is already used for
interventions such as:
– infusions
– SpO2 measurement (loss of data can occur during cuff inflation)
– if an arterio-venous shunt is present.
When a five minute measurement interval is defined for recordings
of 24h duration or more, bruising or decreased blood circulation
can occur in the arm. Only carry out recordings with 5 minute
measurement intervals under constant medical supervision.
It must be certain that, according to the health of the patient, the
use of the device will not damage blood circulation in the arm.
Page 26
BP recording 3
BR-102 plus / BR-102 plus PWA User Guide Safety 3.1
Page 27
3 BP recording
3.2 Applying the Cuff BR-102 plus / BR-102 plus PWA
Page 28
BP recording 3
BR-102 plus / BR-102 plus PWA User Guide Applying the Cuff 3.2
8. Secure BR-102 plus / BR-102 plus PWA to the right or left side of
the patient for preference using the holding pouch and belt
– Ensure that there is enough slack not to strain the hose when the
patient moves. Ensure that the patient is comfortable.
– Tape can be used to secure the tubing to the body if required.
9. When the cuff and device are comfortably positioned, the patient
can replace upper clothing.
Page 29
3 BP recording
3.2 Applying the Cuff BR-102 plus / BR-102 plus PWA
There are five sizes available for the cuff without D-ring:
Page 30
BP recording 3
BR-102 plus / BR-102 plus PWA User Guide Applying the Cuff 3.2
1. Carefully pull the microphone out of the cuff - Do not strain (see
Disconnecting the Pressure Hose and Removing the Microphone
and Bladder, page 47).
2. Remove the foam rubber microphone insert from the adhesive pad
and place the microphone in the pad (metallic (patient) side
outwards), and press to secure with the adhesive.
3. Using an alcohol solution (standard surgical strength) thoroughly
clean the patient‘s arm around the brachial artery area.
4. Wrap the cuff around the uncovered upper arm in such a way that
Art. no.: 2.511076 Rev.: g
Page 31
3 BP recording
3.2 Applying the Cuff BR-102 plus / BR-102 plus PWA
The velcro plaster (set of 10), and the adhesive plaster for the
microphone (set of 10), are available from your local agent.
Page 32
BP recording 3
BR-102 plus / BR-102 plus PWA User Guide Single Measurement 3.3
05:16PM
NEW RECORD
LAST RECORD
SINGLE MEAS.
SYSTEM
NEXT OK
Left Right
Green Blue
Key Key
SCHILLER
3. Using the buttons on the recorder, select:
– Patient Group - Adult / child
– Deflation Speed - 2 to 9 mmHg in 1 mmHg steps, or Auto.
– Pulse beep - on or off. The recorder gives an audible beep with
the detected heart rate.
When auto setting is defined, the deflation rate is set for the detected
heart rate at 3 mmHg per heart beat. The heart rate is ascertained
when the cuff is inflating.
4. Select START
taken.
6. On completion the single measurement is displayed with the
following information:
• Date and time of the measurement
• Recording method used:
– KOR = Auscultatoric (Korotkoff/Riva-Rocci)
– OSC = Oscillometric
• Measurement:
– SYS = Systolic Pressure [mmHg]
– DIA = Diastolic Pressure [mmHg]
– MAP =Mean Arterial Pressure (MAP) in mmHg.
– Pulse = Pulse rate [bpm] (beats per minute)
Page 33
3 BP recording
3.4 Long Term Recording BR-102 plus / BR-102 plus PWA
NEW RECORD
LAST RECORD
SINGLE MEAS.
SYSTEM
NEXT OK
Left Right
Green Blue
Key Key
SCHILLER
NEXT CHANGE
Page 34
BP recording 3
BR-102 plus / BR-102 plus PWA User Guide Long Term Recording 3.4
3.4.2 Program
Selecting a Program
Enter program setup and select Change to select the program (A, B,
C or D). The recording program defined is used when a long term
record is started.
Highlight the recording program to be set and set the start time and
measurement duration for each entry. Up to 8 separate start times can
be defined with the BP measurement interval defined for each start
time.
When less than 8 starts are required pressing next twice returns to the
Art. no.: 2.511076 Rev.: g
Page 35
3 BP recording
3.4 Long Term Recording BR-102 plus / BR-102 plus PWA
Page 36
BP recording 3
BR-102 plus / BR-102 plus PWA User Guide Long Term Recording 3.4
12.02.2014 10:19
KOR
SYS 128 99
MA
mmHg
mmHg
DIA 86 71
PUL
bpm
OK
10. After checking the first measurement and battery display, position
the BR-102 plus / BR-102 plus PWA in the pouch and secure.
Page 37
3 BP recording
3.4 Long Term Recording BR-102 plus / BR-102 plus PWA
Preventive changing the bat- 1. Press the blue button for 4 seconds. Confirm message “Change
teries after 24 hours battery” again with the blue button.
CHANGE BATTERY
Do you want
to change the
battery now?
NO YES
2. Remove the batteries and replace with the fully charged batteries
supplied. Observe correct polarity.
3. Press the green button to switch the unit on. The following
message is displayed:
BP recording . Next measurement. . xx:xx
Changing batteries when The batteries must be changed when an audible indication is given
following audible and mes- and the message Battery LOW - change battery is displayed.
sages are displayed:
WARNING ERROR
NO YES OK
Proceed as follows:
2. Remove the batteries and replace with the fully charged batteries
supplied. Observe correct polarity (see Inserting/Changing the
Batteries, page 15).
3. Press the green button to switch the unit on. The following
message is displayed:
BP recording . Next measurement. . xx:xx
Page 38
BP recording 3
BR-102 plus / BR-102 plus PWA User Guide Long Term Recording 3.4
Press and hold left green Function key for 4 seconds and confirm
with YES - blue right Function key.
NO YES OK NEXT OK
Page 39
3 BP recording
3.4 Long Term Recording BR-102 plus / BR-102 plus PWA
Page 40
Patient Information 4
BR-102 plus / BR-102 plus PWA User Guide Long Term Recording 3.4
4 Patient Information
Danger of strangulation. The shoulder strap or cuff tube can
become entangled around the patient’s neck and lead to
strangulation. The danger increases at night. Ensure the patient is
aware of the danger. The doctor should draw the patient’s
attention to the fact that the cuff must be worn on the upper arm
only and care must always be taken to ensure that neither the
shoulder strap nor the air tube ever become wrapped around the
neck. The air tube must be positioned under a T -shirt or outer
clothing that must continue to be worn at night over the tubing to
help keep it secure.
Tell the patient that if any numbness in the arm, chafing, pain or
discomfort is experienced, the cuff must be removed and to
contact the surgery.
Tell the patient not to get the unit wet - the unit is not waterproof
and must remain dry. If the patient is permitted to take a bath or
shower during the recording (e.g. when taking a 48 hour recording)
it must be emphasised that the recorder and the cuff must be
removed before taking a bath or shower. Instruction should be
given on re-applying the cuff and attaching the device.
Art. no.: 2.511076 Rev.: g
Page 41
4 Patient Information
4.1 General BR-102 plus / BR-102 plus PWA
4.1 General
Inform the patient about the use of the BR-102 plus / BR-102 plus
PWA and instruct the patient on the following points:
• Explain to the patient how to place the cuff correctly and the times
and intervals that measurements will be taken.
• The performance of the BR-102 plus / BR-102 plus PWA can be af-
fected by extremes of temperature, humidity and altitude.
• If taking a 48 hour recording, inform the patient how to change the
batteries. Instruct the patient to keep replacement batteries in the
bag or box provided and not to dispose of the old batteries. Spent
batteries must returned in the bag or container provided.
• Tell the patient that during the measurement:
– Noisy places should be avoided.
– Not to move the arm during the measurements and a recommen-
dation that where possible, the patient relaxes during the meas-
urement process and does not speak.
– Entries must be made in the patient diary during the long-term
measurement.
• The pressure tube and cuff must not be kinked, stretched or sub-
jected to compression or restriction. The air tube may kink when in-
flated. Explain to the patient that particularly when sleeping, the
equipment needs be positioned in such a way that the tube cannot
be compressed. If the patient is not fully competent, the equipment
should be worn only under supervision.
• After an invalid measurement a second measurement will be initiat-
ed immediately.
• The recorder should not be turned off during the recording.
Page 42
Patient Information 4
BR-102 plus / BR-102 plus PWA User Guide Interrupting a measurement during the recording 4.3
If the patient is old or in any way confused, consider asking the patient
to return to the surgery for battery replacement.
obtained. After 10 seconds the cuff is again deflated and ready for the
next programmed measurement.
Page 43
5 Cleaning
5.1 Important Information BR-102 plus / BR-102 plus PWA
5 Cleaning
5.1 Important Information
• Some patients have intolerances (e.g. allergies) to disinfectants or
their components. If you have such a patient or you are not sure, re-
move possible residues with careful washing.
• Ethyl alcohol
• Acetone
• Hexane
Art. no.: 2.511076 Rev.: g
Page 44
Cleaning 5
BR-102 plus / BR-102 plus PWA User Guide Important Information 5.1
The casing of the BR-102 plus / BR-102 plus PWA and the cable
assemblies can be cleaned with a cloth slightly moistened (not wet) on
the surface only. Where necessary a domestic non-caustic cleaner or
70% alcohol solution can be used for grease and finger marks. Wipe
the equipment with a cloth slightly moistened (not wet) with one of
the approved solutions listed above. Wipe off any excess cleaning
solution. Do not let the cleaning solution run into or accumulate in
connector openings, latches, or crevices. If liquid gets into connectors,
dry the area with warm air, and then check the equipment to confirm
that it operates properly.
– Do not clean the whole length in one single action as this may
cause bunching of the sheathing.
– Wipe off any excess cleaning solution. Do not let the cleaning
solution run into or accumulate in connector openings, latches, or
Art. no.: 2.511076 Rev.: g
crevices. If liquid gets into connectors, dry the area with warm air
Page 45
5 Cleaning
5.2 Cleaning the Cuff and Pouch BR-102 plus / BR-102 plus PWA
Page 46
Cleaning 5
BR-102 plus / BR-102 plus PWA User Guide Cleaning the Cuff and Pouch 5.2
1. Disconnect the pressure hose from the cuff inflation bladder con-
nector by twisting the connector a quarter turn.
2. Gently remove the microphone from the microphone pouch by
pushing on the outside of the cuff to move the microphone along
the pouch channel until it can be removed from the cuff.
Page 47
5 Cleaning
5.2 Cleaning the Cuff and Pouch BR-102 plus / BR-102 plus PWA
When re-inserting the bladder, ensure that the correct bladder size is
inserted in the cuff. The bladders come in three sizes and are labelled
accordingly. The bladders are compatible with the D-ring cuffs as
follows:
Page 48
Cleaning 5
BR-102 plus / BR-102 plus PWA User Guide Cleaning the Cuff and Pouch 5.2
Page 49
5 Cleaning
5.2 Cleaning the Cuff and Pouch BR-102 plus / BR-102 plus PWA
Clean the pouch with a damp cotton cloth (do not use corrosive liquids
or solvents) or can be washed in a washing machine at 30°C using a
mild washing powder (do not spin). Do not use fabric softeners or
other aids (e.g. disinfectant rinses). These solutions may leave
residues and damage the material. The Pouch is not suitable for
drying in a tumble dryer.
Page 50
Cleaning 5
BR-102 plus / BR-102 plus PWA User Guide Cleaning the Cuff and Pouch 5.2
5.2.4 Disinfection
The user (doctor) decides, whether and when disinfection of the cuff
sleeve is necessary for reasons of hygiene. Use commercially
available disinfectants intended for clinics, hospitals and practices to
disinfect the device. Disinfect the unit in the same way as described
for cleaning (see Cleaning the Device, page 45). For cleaning and
disinfecting the cuff, wipe with a damp cloth. SCHILLER has tested
and recommends the following solutions:
• Cidex
• Sporicidin
• Mikrozid
• Isopropyl alcohol 70%
• Ethanol 70%
• Buraton fluid
It is vital to observe the manufacturer's instructions for the use of these
products. Always leave the cuff to dry completely.
Page 51
5 Cleaning
5.2 Cleaning the Cuff and Pouch BR-102 plus / BR-102 plus PWA
• Organic solvents
• Ammonia-based detergent
• Abrasive cleaning agents
• 100% alcohol, Virex, Sani-Master
• Sani-Cloth®, Ascepti® or Clorox® wipes
• HB Quat®
• Conventional cleaner (e.g. Fantastic®, Tilex® etc.)
• Conductive solution
• Solutions or products containing the following ingredients:
– Ketone (for ex. acetone)
– Ammonium chloride
– Betadine
– Chlorine, wax or wax compound
– Sodium salt
5.2.7 Sterilisation
The cuff can be sterilised with Ethylene oxide gas. Prepare the cuff as
detailed previously. After sterilisation the parts that were exposed to
the gas must be aired.
Page 52
Maintenance 6
BR-102 plus / BR-102 plus PWA User Guide Visual Inspection 6.1
6 Maintenance
All maintenance work must be carried out by a qualified technician
authorised by SCHILLER AG. Only maintenance procedures given in
this book may be carried out by the user.
Page 53
6 Maintenance
6.2 Battery Maintenance BR-102 plus / BR-102 plus PWA
• Full capacity of new NIMH batteries are only reached after three
charge/discharge cycles.
• Totally discharged batteries require approximately three hours to be
fully charged (with two batteries in charger), or six hours (with four
batteries in charger).
• Charged batteries lose their charge when removed from the charg-
er unit. Therefore to ensure full capacity only remove the batteries
from the charger immediately before taking a recording.
• No harm will be done to the batteries by leaving them in the charger
unit.
Remove the batteries from the BR-102 plus / BR-102 plus PWA (see
Inserting/Changing the Batteries, page 15), and place in the battery
charger unit. Leave the batteries in the charger unit until fully charged
(see battery charger operating instructions).
Page 54
Maintenance 6
BR-102 plus / BR-102 plus PWA User Guide Calibration 6.3
6.3 Calibration
DEVICE INSPECTION The unit must be returned to a SCHILLER approved centre for
Time limit calibration at the interval defined by local regulations or at least every
22 day(s)
Call SCHILLER two years. A reminder message is displayed 30 days before
service! calibration is due and counts down the subsequent days every time
ok the unit is switched on.
6.4.2 Setup
Art. no.: 2.511076 Rev.: g
Page 55
6 Maintenance
6.4 Measurement Check BR-102 plus / BR-102 plus PWA
TEST CALIBRATION
Cuff pressure
180
mmHg
OK
4. The pressure will slowly drop. Check the reading on the BR-102
plus / BR-102 plus PWA against the calibrated pressure gauge.
The two measurements should be within 3 mmHg. After 120
seconds the BR-102 plus / BR-102 plus PWA releases the
pressure.
Page 56
Maintenance 6
BR-102 plus / BR-102 plus PWA User Guide Measurement Check 6.4
Adult
1. Set / check that Adult is set in the record setup. This can be done
for single measurement or new record:
Page 57
6 Maintenance
6.5 Error Messages BR-102 plus / BR-102 plus PWA
by relief valve.
140 Meas. invalid • Evaluation impossible (KOR). Check position of microphone; repeat
measurement.
150 Meas. invalid • Evaluation impossible (OSC). Check cuff; avoid moving the arm.
180 No signal • Pressure reached 70 mmHg Connect microphone. Check microphone
and no Korotkoff signal de- position.
tected.
181 Weak signal • Pressure reached 50 mmHg Place microphone over brachial artery;
and no Korotkoff signal de- ensure that the microphone is correctly
tected. orientated (metallic side towards arm).
Page 58
Maintenance 6
BR-102 plus / BR-102 plus PWA User Guide Error Messages 6.5
Page 59
7 Technical Data
6.5 Error Messages BR-102 plus / BR-102 plus PWA
7 Technical Data
Device Name BR-102 plus / BR-102 plus PWA
Dimensions 100 x 68 x 28 mm (l x w x h)
Weight 200 grams (including rechargeable batteries)
Display Graphical colour OLED with multi-language menu
Power Supply
Power consumption 2.4 V, 4.0 VA
Batteries Type AA, 2 rechargeable NiMH, 1.2 V, 2700 mAh
Capacity 24 hours (approximately 100 measurements can be performed)
Battery capacity indicated on the display
Data Storage Flash memory with capacity for over 400 measurements and 30 sec.
of voice recording
Page 60
Technical Data 7
BR-102 plus / BR-102 plus PWA User Guide Error Messages 6.5
Trusted Accuracy The BR-102 plus / BR-102 plus PWA is clinically validated to all
internationally recognised organisations:
Environmental Conditions
(storage and transport)
Transport temperature • - 10°C to + 50°C (+ 14°F to + 122°F)
Storage temperature • + 5°C to + 50°C (+ 41°F to + 122°F)
Relative humidity (storage • 10 % to 95 % (non-condensing)
and transport)
Art. no.: 2.511076 Rev.: g
Page 61
7 Technical Data
7.1 Preventing electromagnetic interferences BR-102 plus / BR-102 plus PWA
- Walkie-talkies (FRS)
430-470 450 2 0.3
- Rescue service, police, fire brigade, servicing (GMRS)
LTE band 13/17 704-707 710/745/780 0.2 0.3
- GSM800/900
- LTE band 5 800-960 810/870/930 2 0.3
- Radio telephone (microcellular) CT1+, CT2, CT3
- GSM1800/1900
- DECT (radio telephone) 1720/1845/
1700-1990 2 0.3
- LTE Band 1/3/4/25 1970
- UMTS
- Bluetooth, WLAN 802.11b/g/n
- LTE Band 7
2400-2570 2450 2 0.3
- RFID 2450 (active and passive transponders and reading de-
vices)
5240/5500/
WLAN 802.11a/n 5100-5800 0.2 0.3
5785
Page 62
Accessories 8
BR-102 plus / BR-102 plus PWA User Guide Documentation 8.1
8 Accessories
Always use SCHILLER replacement parts and disposables, or
products approved by SCHILLER. Failure to do so may endanger
life and invalidate the guarantee.
8.1 Documentation
Part Number Description
2.511043 medilogDARWIN2 User Guide DE
2.511044 medilogDARWIN2 User Guide EN
2.511045 medilogDARWIN2 User Guide FR
2.511064 medilogDARWIN2 User Guide ES
2.511065 medilogDARWIN2 User Guide SV
2.511066 medilogDARWIN2 User Guide RU
2.511067 medilogDARWIN2 User Guide ZH-S
2.540045 BR-102 plus / BR-102 plus PWA Recurrent test and service handbook
Page 63
8 Accessories
8.3 Cuff and Cuff Accessories BR-102 plus / BR-102 plus PWA
Page 64
BR-102 plus PWA 9
BR-102 plus / BR-102 plus PWA User Guide Overview 9.1
The central arterial pulse wave is the sum of the forward pressure
wave generated by left ventricular ejection and a backward
propagating wave that is subsequently reflected from the peripheral
site. The time point at which these forward and backward propagating
waves merge and the amplitude of the reflected (backward) wave
affect the level of central BP.
9.2 Measurements
After every BP measurement, the cuff is again inflated to the diastolic
pressure and held for 10 seconds while PWA data is obtained (see
BR-102 plus PWA Unit Measurements, page 43).
• Augmentation pressure
• Augmentation index
• Alx@75 [90% confidence interval]
• Peripheral resistance
• Pulse Wave Velocity [PWV]
Page 65
9 BR-102 plus PWA
9.4 Method BR-102 plus / BR-102 plus PWA
9.4 Method
Ten pulse waves are filtered and averaged to determine the central
arterial pulse wave. The augmentation index is standardised for a
pulse rate of 75 bpm (see reference [1]). This parameter is then
described as Alx@75.
Male
60
50
40 90% CI
30 mean
Alx@75
20 90% CI
10
0
-10
-20
20 30 40 50 60 70
Age
Female
60
50
90% CI
40
mean
30
Alx@75
90% CI
20
10
0
Art. no.: 2.511076 Rev.: g
-10
-20
20 30 40 50 60 70 80
Age
Average value and 90% confidence interval for the Alx@75
Page 66
Patient Diary 10
BR-102 plus / BR-102 plus PWA User Guide Patient Diary Example 10.1
10 Patient Diary
10.1 Patient Diary Example
The patient diary template is delivered with the unit (in Word format
and PDF format) for direct printing. A sample is reproduced on the
following pages for information or copying if required.
Art. no.: 2.511076 Rev.: g
Page 67
SCHILLER BR-102 plus / BR-102 PWA
Patient Diary
Patient ID: …............................................................................................................................................
WARNING
• If you experience any numbness in the arm, chafing, pain or discomfort remove the cuff and contact
your doctor immediately.
• Danger of strangulation from the hose. Ensure a T-shirt or outer clothing is worn over the hose and
unit at night.
• The BR-102 plus/PWA must not be used in the vicinity of an MRI scanner.
CAUTION
• The unit is not waterproof, do not get wet - remove the recorder and cuff if you take a bath or shower.
NOTE
• If using the BR-102 plus/PWA outdoor at significant lower temperature as 5°C, make sure that you
wear a warm long coat to keep the device temperature above 5°C. Significant lower temperature may
reduce the battery performance and therefore the max. recording time.
BR-10 plus
DURING THE RECORDING
• Do not to move the arm during the measurements.
• Avoid noisy areas when a measurement is being taken.
• If an invalid measurement is made, a second measurement will be initiated immediately.
• The unit must continue to be worn during the night time period. Wear a T-shirt or continue
to wear normal outer clothing over the tubing at night to help keep it secure.
Control buttons
• If you have a PWA monitor a second phase is initiated after every measurement: the cuff
is again re-inflated and remains inflated for approximately 10 seconds before deflating
ready for the next measurement.
• Or when the audible beep is heard and one of the following messages are displayed:
BATTER Y L OW BATTER Y L OW
Ch ang e Ch ang e battery
ba ttery imme dia te ly
NO YES OK
Cuff placement
The cuff should be placed on the left upper arm approximately 2cm above the elbow so that the forearm
can move. Position the MICRO symbol (if present) on the inside of the arm. The pressure tube points
towards the shoulder. Tape can be used to hold the tubing to the body if required. Place the device in the
pouch and secure with the pouch straps. Wear a t-shirt over the tubing to help secure the tubing in
position.
Make an entry in this diary (next page) if you experience any dizziness, palpitations, chest pain, etc. Also
make an entry when the batteries are changed, an extra measurement is taken, or for any other event.
SCHILLER BR-102 plus / BR-102 PWA
Patient Diary
11 Index
B Pressure Hose and Microphone
Connection ...................................... 16
Battery
Capacity Display ............................ 20 Pulse Wave Analysis ........................ 65
Changing During a Recording (48
hour) ................................................. 38 R
Condition .......................................... 20
RECORD SETUP .............................. 35
Disposal ........................................... 54
Maintenance ................................... 54
Recording ............................................ 26
Replace ............................................ 15
S
C Safety Notes ......................................... 7
Calibration ........................................... 52 Safety Symbols ........................ 11, 13
Checking the Measurements ........... 55 SD memory card ................................ 17
Cleaning the pouch ............................ 50 Settings ................................................ 25
Cuff Single Measurement ......................... 33
Applying ........................................... 28 Starting a Recording ......................... 36
Cleaning ........................................... 46 Stopping the Recording .................... 39
Size ................................................... 28 Switching off ....................................... 19
Switching on ....................................... 18
D
Displaying a Recording on the BR-102 T
plus ....................................................... 39
Taking an extra measurement during the
recording ............................................. 42
E Technical Data ................................... 60
Electromagnetic Radiation ............... 62 Time Display ....................................... 20
Error Messages .................................. 58
U
I Unpacking ........................................... 13
Interrupting a measurement during the
recording .............................................. 43
V
Visual Inspection ................................ 53
L
Lithium Batteries ................................ 21
Long Term Recording ....................... 34
M
Art. no.: 2.511076 Rev.: g
O
Operating and Display Elements .... 18
P
Patient Diary ....................................... 65
Patient Information ............................ 41
Page 71
Appendix - Symbols 12
12 Appendix - Symbols
This appendix lists all general symbols that may be present on the
device, label and accessories. Not all of those symbols are necessarily
present on your device.
This appendix has its own article number, which is independent of
the user guide's article number.
Medical device
Serial number
Reference number
Batch code
Catalogue number
Quantity
Do not reuse
Latex-free
Consult instruction for use (indicates the need for the user to con-
sult the instructions for use)
EIP = electronic information product (dos not contain any toxic and
hazardous substances or elements above the maximum concentra-
tion values (product can be recycled and re-used).
Art.-No.: 2.520164 Rev. a
Americas France Serbia
SCHILLER Americas Inc. SCHILLER Médical SCHILLER d.o.o.
Doral, Florida 33172 F-67160 Wissembourg 11010 Beograd
Phone +33 3 88 63 36 00 Phone +381 11 39 79 508
North America: Fax +33 3 88 63 36 49 Fax +381 11 39 79 51 8
Phone +1 786 845 06 20 info@schiller.fr info@schiller.rs
Fax +1 786 845 06 02 www.schiller-medical.com www.schiller.rs
sales@schilleramericas.com
www.schilleramericas.com France (distribution France) Slovenia
Latin America & Caribbean SCHILLER France S.A.S. SCHILLER d.o.o.
Phone +1 305 591 11 21 F-77608 Bussy St Georges 2310 Slovenska Bistrica
Fax +1 786 845 06 02 Phone +33 1 64 66 50 00 Phone +386 2 843 00 56
sales@schilleramericas.com Fax +33 1 64 66 50 10 Fax +386 2 843 00 57
www.schilleramericas.com contact@schillerfrance.fr info@schiller.si
www.schiller-france.com www.schiller.si
EN: European Authorised Representative, DE: Europäischer Bevollmächtigter, CZ: Evropský zmocněný zástupce, SCHILLER Medizintechnik GmbH
ES: Representante Europea Autorizada, FR: Représentant autorisé européen, HU: Meghatalmazott európai képviselő, Otto-Lilienthal-Ring 4
HR: Europski ovlašteni predstavnik, IT: Rappresentante autorizzato per l‘Europa, LT: Europos įgaliotasis atstovas, 85622 Feldkirchen
LV: Eiropas pilnvarotais pārstāvis, NL: Gemachtigde Europese vertegenwoordiger, NO: Europeisk autorisert representant, Germany
PL: Autoryzowany przedstawiciel w Europie, PT: Representante Autorizado Europeu, RO: Reprezentant autorizat European,
SR: Evropski ovlašćeni predstavnik, SV: Europeiska auktoriserade representanten, SK: Európsky splnomocnený zástupca,
SL: Evropski pooblaščeni zastopnik, FI: Euroopan valtuutettu edustaja, zastopnik, BG: Evropeĭski otoriziran predstavitel
EL: Ευρωπαίος Εξουσιοδοτημένος Αντιπρόσωπος.
CTU
U FA RE
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LT Book für
SWITZE
inhouse-Druck
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FA C T U R
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Manufacturer: SCHILLER AG, Altgasse 68, CH-6341 Baar, Switzerland, Phone + 41 41 766 42 42, Fax + 41 41 761 08 80, sales@schiller.ch, www.schiller.ch
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