Welch Allyn ABPM 7100 Manual

ABPM 7100 Ambulatory Blood Pressure Monitor
Directions for Use
EN
使用说明书
ZH
Brugsvejledningen
DA
Gebruikshandleiding
NL
Käyttöohjeet
FI
Mode d'emploi
FR
Bedienungsanleitung
DE
Istruzioni per l'uso
IT
Bruksanvisning
NO
Instruções de Utilização
PT
Instrucciones de uso
ES
Bruksanvisning
SV

ABPM 7100
Ambulatory Blood Pressure Monitor
Directions for Use
2
© 2014 Welch Allyn, Inc. To support the intended use of the product described in this publication, the
purchaser of the product is permitted to copy this publication for internal distribution only, from the media
provided by Welch Allyn.
Caution: Federal US law restricts sale of the device identified in this manual to, or on the order of, licensed
physicians.
Welch Allyn does not accept liability for injuries or unlawful or improper use of the product which may result
from the fact that the product is not used in accordance with the instructions, cautions and warnings, as well
as the indications for use published in this manual.
Welch Allyn is a registered trademark of Welch Allyn, Inc., ABPM 7100 and CardioPerfect are trademarks of
Welch Allyn, Inc.
The copyright for the firmware in this product remains with the manufacturer of this device. All rights
reserved. The firmware may not be read out, copied, decompiled, redeveloped, disassembled or brought into
any human-readable format. This does not pertain to the sales of firmware or a firmware copy. All usage and
ownership rights to the Software remain with I.E.M. GmbH.
Welch Allyn Technical Support:
http://www.welchallyn.com/about/company/locations.htm
I.E.M. GmbH
Cockerillstr. 69
52222 Stolberg
Germany
Manufactured for Welch Allyn
EN

3 - Table of contents
Table of contents
Symbols 4
Introduction 5
Preliminary note 5
About these directions for use 5
Clinical data 5
CE Mark 5
Content 6
Direction for use 6
Intended use 6
Indications for use 6
Contraindications 6
Essential Performance 7
Side effects of 24-hour blood pressure monitoring 7
Product description 7
Introduction 7
The ABPM 7100 8
Technical Data 10
Preparing the ABPM 7100 11
Safety instructions 11
Inserting the batteries 12
Activating the device 13
Setting the time / date 13
Clearing the memory 13
Transferring patient data (ID) 14
Setting measurement logs 14
Selecting a suitable cuff 15
Applying the ABP Monitor and cuff 15
Connecting the cuff tubing to the ABPM 7100 17
Positioning the patient for measurement 18
Measurement process 18
Safety instructions 18
Initial measurement 20
24-hour measurement 20
Performing a measurement 20
Cancelling a measurement 21
Unsuccessful measurement 21
Care and Maintenance 21
Cleaning 21
Disinfection 22
Maintenance plan 22
Troubleshooting 23
Basic error sources 23
Transmission error 23
Checklist 23
Error codes 24
Limited Warranty 27
Service Policy 27
EMC Guidelines and Manufacturer Declaration 28
Compliance 31
Patient Information - operation of the ABPM 7100 33
Symbols - 4
Symbols
Documentation symbols
WARNING The warning statement
identifies an immediate threat. Non-
adherence may lead to the most severe
injuries and to death
CAUTION The caution statement
identifies a possible hazard. Non-
adherence may lead to minor or
moderate injuries
Attention The attention statement marks possible
material damage. Non-adherence may
lead to damage to the device or its
accessories
Note The note statement marks further
information on the ABPM 7100 or its
accessories
INTERNAL REFERENCE Marks
references within the document to further
information
EXTERNAL REFERENCE Marks
references to external documents
containing further optional information
Mandatory – Consult Directions for Use Meets essential requirements of
European Medical Device Directive
93/42/EEC
Consult Directions for Use, Electronic
version available at Welchallyn.com, or
Hard copy DFU available from Welch
Allyn within 7 days.
Power symbols
Battery symbol indicates the type of
power supply
Nonionizing electromagnetic radiation
Connectivity symbols
FCC ID and IC
Bluetooth Connectivity
Shipping, storing and environment symbols
Separate the device from other
disposables for recycling.
See www.welchallyn.com/weee
Miscellaneous symbols
Manufacturer
yyyy-mm
Date of manufacture
Reference/Model number Serial number
Reorder/Catalog number Batch code
Global Trade Item Number Protection class
Defibrillation-proof type BF applied part

5 - Introduction
Introduction
Preliminary note
With the ABPM 7100 24-hour blood pressure measuring device, you now have an Ambulatory Blood
Pressure Monitoring System (ABPM System) at your disposal.
The ABPM 7100, also specified as ABP Monitor, can be prepared for a new patient in just a few minutes.
This permits the optimum use of the ABP Monitor and allows you to process one 24-hour profile per day.
The ABPM 7100 can therefore be quickly integrated into everyday practice life. The recorded blood pressure
values must be evaluated with the intended software.
In combination with the Hypertension Management Software and an appropriate license, the ABPM 7100 is
also able to process a haemodynamic analysis of the recorded pulse waves.
About these directions for use
These directions for use will familiarize you with the use of the ABPM 7100 and its accessories.
The software CardioPerfect Workstation (CPWS) is used for measurement evaluation.
Upgrades for haemodynamic evaluation may also be purchased from Welch Allyn. Please contact Welch
Allyn for further information.
With reference to specific version characteristics, only the parts relevant for your respective version will
apply.
•PleaserefertotheCPWSdirectionsforuseforsoftware operating instructions.
•Fortheupgradespleaserefertotherespectivedirections for use to operate the
Hypertension Management Software (HMS), version 5.0 and above.
Note These directions for use explain the ABPM 7100 and its accessories in the sequence in which
you setup the device for a blood pressure measurement, followed by the installation, initial
operation, measurement preparation, placement on the patient and the evaluation. Individual
functions are only explained when they are needed. You will therefore be familiarized with the
ABPM 7100 on a step-by-step basis.
This directions for use must be kept with the product for later use!
Clinical data
The blood pressure measuring device ABPM 7100 fulfills the requirements of the ESH (European Society of
Hypertension), BHS (British Hypertension Society) and ISO 81060-2.
The device has not been tested on pregnant women, including preeclamptic patients.
CE Mark
The ABPM 7100 fulfills the requirements of the following directives:
•Directive93/42/EEC(MDD)
•Directive1999/5/EC(R&TTE)
•Directive2011/65/EU(RoHS)
The ABPM 7100 bears the CE mark.
Direction for use - 6
Content
Standard
1. ABPM 7100 Monitor
2. Pressure Cuff – Size “Adult”
3. Carrying Pouch
4. PC Interface Cable
5. 4x AA Alkaline Batteries
6. ABPM 7100 Directions For Use
7. Calibration Notice
8. CPWS Software (dependent on set)
9. Pressure Cuff – Size “Adult Plus” (dependent on set)
HMS Option
1. HMS Software
2. Bluetooth
®
-Dongle
3. Quick Start Guide (dependent on upgrade
option)
4. Version dependent 16 digit License Code
(dependent on upgrade option)
Warning
Risk of injury posed by the use of other accessories. The use of unapproved accessories may
lead to incorrect measurement results.
•Onlyuseaccessoriesapprovedanddistributedbythe manufacturer and Welch Allyn.
•Checktheaccessoriesregardingthemanufacturer’sinformation before first use.
Direction for use
Intended use
The ABPM 7100 is intended for clarifying the blood pressure status and for use as a diagnostic aid for an
individual patient (in the patient’s environment). The ABPM 7100 may only be used under medical
supervision and after detailed instruction has been provided by the doctors or healthcare professionals. The
ABPM 7100 in combination with the Hypertension Management Software (HMS) provides a derived
ascending aortic blood pressure wave form and a range of central arterial indices. Analysis based on the
recordings is in the sole responsibility of the medical professional.
Indications for use
•TheABPM7100isanautomated,microprocessorcontrolled ambulatory blood pressure monitor
(ABPM) which records, accumulates and stores: heart beat (rate), systolic and diastolic data of an
individual patient (in the patient’s environment) for a session which may last 24 hours.
•Itisusedwithastandardupper-armcuffforblood pressure measurement.
•TheABPM7100incombinationwiththeHypertensionManagement Software (HMS) provides a derived
ascending aortic blood pressure wave form and a range of central arterial indices. It is used in those
adult patients, where information related to the ascending aortic blood pressure is desired, but in the
opinion of the physician, the risk of cardiac catheterization procedure or other invasive monitoring may
outweigh the benefits.
Contraindications
•TheABPM7100mustnotbeusedonneonatesandchildren under the age of 3 years!
•Duetothestrangulationriskposedbytubingandcuff, the ABPM 7100 must not be placed within reach
of unsupervised children, and must not be used on unsupervised patients with limited cognitive abilities,
or patients under anesthetics!
•TheABPM7100isnotintendedforalarmtriggeringmonitoring purposes in intensive care units, and
must not be used for blood pressure monitoring purposes in intensive care units or during surgery!
EN

7 - Product description
Essential Performance
The main performance features are defined as blood pressure measurement with:
•Errortolerancesofthepressuregaugeandmeasurement results are within required limits (IEC
80601-2-30).
•Maximumchangevalueinbloodpressuredetermination is as specified in IEC 80601-2-30.
•Cuffpressurizationremainswithinspecifiedlimits (IEC 80601-2-30).
•Anerrorisissuedintheeventthatsuccessfulblood pressure measurement is impossible.
The ABPM 7100 does not issue ALARMS pursuant to IEC 60601-1-8 and is not intended for use in
connection with HF surgical equipment or to clinically monitor patients in intensive care units.
Basic safety means that the patient cannot be endangered by any automatic device procedure. During any
unclear conditions, the ABPM 7100 must therefore transfer into the safe Standby mode, during which the
ABPM 7100 cannot automatically inflate the cuff, while this can be manually triggered by pushing the START
button.
In this context, any interruption of a measurement or in automatic operation by an external influence, or the
ability of the ABPM 7100 to test error conditions, is regarded as the retention or restoration of basic safety,
and not as non-adherence to the main performance features.
Side effects of 24-hour blood pressure monitoring
As with occasional blood pressure measurements, petechiae, haemorrhages or subcutaneous haematoma
may occur on the measured arm despite a correctly seated cuff. The innate patient-dependent risk resulting
from treatment with anticoagulants or in patients with coagulations disorders arises irrespective of the type of
monitoring device. Always check whether the patient displays coagulation disorders or is being treated with
anticoagulants.
Product description
Introduction
The ABPM 7100 System consists of two main components:
•TheABPM7100withcuffsandaccessories
•Patientmanagementsoftwareforthedoctortoevaluate the measurement results
With the CPWS software the ABPM 7100 can be prepared for measurement, transfer stored measurement
results to the PC, display transferred measurements on the screen in various formats such as graphics, lists
and statistics and print out measurement results. Optional is the possibility to evaluate the measurement
results with the HMS and its upgrades.
The ABPM 7100 can be prepared immediately for the next patient. With little practice this procedure can be
completed in just a few minutes. This allows the doctor to use the ABPM 7100 around the clock on each
work day.
The ABPM 7100 is designed to allow recording and display of a blood pressure profile throughout the day
and at night. Additional parameters such as nocturnal values and blood pressure fluctuations are recognized.
This permits the doctor to prescribe optimal medical treatment for each individual.
Measurement with the ABPM 7100 can be either automated or be manually controlled by the user. In order
to start a series of automatic measurement, the user must initiate the first measurement by pressing the
START button and the doctor should check the reliability of the first measurement.
During the first measurement, the cuff is inflated in increments, to determine the cuff pressure required to
measure the systolic blood pressure value. The maximum required inflation pressure is stored and applied
by direct inflation during the subsequent automatic measurements. This procedure is called AFL – Auto
Feedback Logic.
Product description - 8
The ABPM 7100
Components
1
2
3
4
5
6
7
Cuff connection
ON/OFF button
LCD-Display
START button
DAY/NIGHT button
EVENT button
PC Interface cable port
The Buttons
ON/OFF
The ON/OFF button turns the ABPM 7100 on and off. To prevent unintended activation,
the ABPM 7100 turns on or turns off only when the button is pressed for more than 2
seconds.
START
The START button serves to
•initiate a manual measurement to ascertain whether the ABPM 7100 is working correctly.
•initiate a 24-hour measurement.
•perform a measurement outside the specified measurement cycle.
DAY/NIGHT
The DAY/NIGHT button is used to differentiate between waking and sleeping phases
during the measurement, which is important for statistics and the graphic displays.
The patient is instructed to press the DAY/NIGHT button upon going to bed and again,
when getting up in the morning. This individually adapts the measurement interval to the
patient and assists you in the analysis of the blood pressure profile.
EVENT
The patient uses the EVENT button to document the time of medication or to record any
events which may cause the blood pressure to rise or fall. Pressing the button will trigger a
measurement, the patient should note the reason for pressing the EVENT button in the
event log.
LCD Display
The LCD display is located on the front of the ABPM 7100 casing. It displays useful information for the doctor
and the patient regarding measurement data, monitor settings and measurement errors. When the START
button is pressed, the number of previously registered measurements will be shown before starting a manual
measurement.

9 - Product description
Audible signals
Individual or multiple beeps of audible signals are used. The following table explains the meaning of the
beeps:
1 beep
• SwitchingON/OFF
• Startingandendingameasurement(exceptatnightintervals)
• Removaloftheinterfacecable
• EstablishingandendingBluetooth®communication
• Measurementerrors
3 beeps
• Systemerrors
Continuous beeps
• Severesystemerrors(e.g.cuffpressureishigherthan 15 mmHg for longer than
10 seconds outside the measurement)
Combined beeps
• Manualdeletionofmeasurement,1beepfollowedby5 beeps 2 seconds later
Cuff connection
• ThecuffconnectionislocatedatthetopoftheABPM 7100 casing.
• ThecuffisconnectedtotheABPM7100viaametalconnector.
Attention
Measurement
e
rror
s
• Thecuffconnectionmustalwaysengagewithanaudible “ CLICK “. A poor connection between the
ABPM 7100 and cuff will result in measurement errors.
The Arm Cuff
1
2
3
The arm cuff
Air tube
Air tube connection
PC Interface Cable
In order to read data from the ABPM 7100, the interface cable must be connected to an USB slot on a PC.
Product description - 10
PC Interface Cable Port
• TheconnectingportforthePCinterfacecableislocated at the bottom of the ABPM 7100 casing.
• Thereddotontheplugmustalignwiththereddot on the port before plugging.
• Todisconnect,pullontheknurledringoftheconnector.
Connecting the ABPM 7100 to the PC
To transfer the data from the ABPM 7100, ensure that the interface cable is connected correctly to an USB
port on the PC and to the interface cable port on the device.
Technical Data
Measurement pressure range: Systolic 60 to 290 mmHg
Diastolic 30 to 195 mmHg
Accuracy: +/- 3 mmHg in display range
Static pressure range: 0 to 300 mmHg
Pulse range: 30 to 240 beats per minute
Procedure: oscillometric
Measurement intervals: 0, 1, 2, 3, 4, 5, 6, 10, 12, 15, 20 or 30 measurements per hour
Measurement logs: 4 adjustable interval groups
Memory capacity: 300 Measurements
Battery capacity: > 300 Measurements
Operating temperatures: +5°C to +40°C
Operating humidity: 15% to 93%
Storage environment: -25°C to +70°C and 15% to 93% humidity
Dimensions: 121 x 80 x 33 mm
Weight: approx. 220 g excluding batteries
Power supply: 2 Ni-MH batteries with 1,2 V each and min. 1500 mAh (AA, Mignon) or
2 Alkali 1,5 V batteries (AA, Mignon, LR6)
Interfaces:
USB-Interface cable
Bluetooth® (Class 1 / 100 m and max. 100 mW with 2,402 GHz to
2,480 GHz) only available with optional HMS software
Expected operational device life: 5 Years
Expected operational cuff life: 6 Months
EN

11 - Preparing the ABPM 7100
Preparing the ABPM 7100
Safety instructions
Warning
Risk of strangulation posed by the shoulder strap and cuff tubing.
•Ifthepatienthaslimitedcognitiveabilities,the device may only be used under supervision.
•Donotplacetheshoulderstrapandcufftubingaround the patient’s neck.
•Alwaysplacethecufftubingundertheouterclothing (even at night).
•Whenusedonchildren,thedevicemustonlybeapplied with special care and under permanent
supervision.
•Instructthepatienttoturnoffthedevice,remove the cuff, and notify the doctor if they are
experiencing pain, swelling, redness or numbness in the limb where the cuff is placed. (It is expected
that the patient may experience some mild to moderate discomfort during a blood pressure
measurement.)
•Measurementcanbeinterruptedatanystagebypushing any of the buttons. This deflates the cuff
and the device can be removed.
Warning
In
very rare cases materials used for and on the cuff may cause allergic reactions.
•Donotusethecuffonpatientswithaknownhypersensitivity to epoxy resin.
Caution
Risk of injury caused by incorrect application of the device.
•Thedoctormustensurethat,duetothepatient’smedical condition, the use of the device and the
cuff does not result in impaired blood circulation.
•Ifthepatienthaslimitedcognitiveabilities,the device may only be used under supervision.
•Whenusedonchildren,thedevicemustonlybeapplied with special care and under permanent
supervision.
•Whileitisstillattachedtoapatient,thedevice may never be connected to a PC or other device.
•Instructthepatienttoplacethedeviceinsuchaway that, while the cuff is inflated, the tubing is not
compressed or kinked, especially during sleep.
•Petechiae,haemorrhagesorsubcutaneoushaematomamay occur in some patients.
•Instructthepatienttoturnoffthedevice,remove the cuff, and notify the doctor if they are
experiencing pain, swelling, redness or numbness in the limb where the cuff is placed. (It is expected
that the patient may experience some mild to moderate discomfort during a blood pressure
measurement.)
Caution
Risk of injury caused by incorrect
application of the cuff.
•Thedoctormustensurethat,duetothepatient’smedical condition, the use of the device and the
cuff does not result in impaired blood circulation.
•Ifthepatientishaslimitedcognitiveabilities,the device may only be used under supervision.
•Whenusedonchildren,thedevicemustonlybeapplied with special care and under permanent
supervision.
•Itisimperativethatyouinstructthepatientinthe correct seating of the cuff.
•Informthepatientthatthecuffmayonlybeusedon the upper arm.
•Ensurethatneithertheshoulderstrapnorthecuff tubing can ever wrap around the patient’s neck.
Always place the cuff tubing under the outer clothing (even at night).
•Instructthepatienttoplacethedeviceinsuchaway that, while the cuff is inflated, the tubing is not
compressed or kinked, especially during sleep.
•Petechiae,haemorrhagesorsubcutaneoushaematomamay occur in some patients.
•Instructthepatienttoturnoffthedevice,remove the cuff, and notify the doctor if they are
experiencing pain, swelling, redness or numbness in the limb where the cuff is placed. (It is expected
that the patient may experience some mild to moderate discomfort during a blood pressure
measurement.)
Preparing the ABPM 7100 - 12
Caution
Intolerances caused by the
use of disinfectants.
• Washtoremoveresidues.
• Washthecuffsleevewithamilddetergentinthewashing machine at max. 30°C without spinning.
Inserting the batteries
Attention
Damage to device
• DonotweartheABPM7100whileshowering!Ifyoususpect that liquid has entered the device while
cleaning or using it, the device shall no longer be used on the patient.
• Ifthedevicewasexposedtomoisture,switchoffthe device and remove the batteries.
• Informyourserviceimmediatelyandsendthedevice in for inspection.
• ThedevicemaynotbeoperatedaroundMRIscannersor in the immediate vicinity of other medical
electrical equipment.
• Duringadefibrillatordischarge,thedeviceshallnot be in contact with the patient. Such a discharge
may damage the ABPM 7100 and cause it to display incorrect values.
• TheABPM7100isnotsuitableforsimultaneoususewith HF surgical equipment.
• Measurementcanbeinterruptedatanystagebypushing a random button. This deflates the cuff and
the device can be removed.
Attention
Device function
• Althoughzinc-carbonbatteriesmayindicatesufficient voltage during a battery test, their output is
frequently insufficient to perform 24-hour measurements.
• Toconductmeasurementsover48hours,youwillneed 2 additional batteries as replacement after
24 hours.
Attention
Damage to device
• Donotopenthecasing.Oncethedeviceisopened,all warranties will lapse.
Open the batteries compartment on the rear of the ABPM 7100 casing to insert the batteries into the ABPM
7100 according to the battery polarities (+ / -) and close the compartment.
Note •
Alwaysusefullychargedbatteriesforanewmeasurement
• Onlyuseundamagedbatteries
• Pleaseremovethebatteriesifthedevicehasnotbeen used for a longer period
• Wheninsertingthebatteries,pleaseensurecorrect polarity

13 - Preparing the ABPM 7100
Activating the device
Attention
Damage to device
•DonotweartheABPM7100whileshowering.Ifyoususpect that liquid has entered the device while
cleaning or using it, the device shall no longer be used on the patient.
•Inthedevicewasexposedtomoisture,switchoffthe device and remove the batteries.
•Informyourserviceimmediatelyandsendthedevice in for inspection.
•ThedevicemaynotbeoperatedaroundMRIscannersor in the immediate vicinity of other medical
electrical equipment.
•Duringadefibrillatordischarge,thedeviceshallnot be in contact with the patient. Such a discharge
may damage the ABPM 7100 and cause it to display incorrect values.
•TheABPM7100isnotsuitableforsimultaneoususewith HF surgical equipment.
•Measurementcanbeinterruptedatanystagebypushing a random button. This deflates the cuff and
the device can be removed.
Attention
Hygiene
•Ensurehygieneinaccordancewiththemaintenanceschedule.
Always check the condition of the ABPM 7100 by observing the initial display shown on the device shortly
after turning it on and before handing it to a patient. The ABPM 7100 performs a self-test. In addition, a beep
sounds to check the speaker. The following should be displayed in this sequence:
Test Display Comment
Battery condition (volts) 2.85 (At least 2.6 volts for NiMH batteries and at least 3.10 volts for alkaline
batteries)
Display Segment Test 999:999 to
000:000
The display of the figures (999:999 to 000:000) is accompanied by all
other symbols of the LCD in succession. Check whether all segments
are correctly and fully displayed (the complete program code is
checked for correctness in the background)
Current 24h time 21:45 hh:mm
If the internal test detects an error, the ABPM 7100 will indicate “E004” on the display and emit an audible
signal. For safety reasons, the use of the ABPM 7100 will be locked. The faulty ABPM 7100 unit should be
send back immediately for repairs to your dealer or to Welch Allyn.
Setting the time / date
The ABPM 7100 has an internal buffer battery allowing the time to continue even if the batteries have been
removed. Nevertheless the time and the date should be checked before every measurement series.
The time and date can be set automatically with the patient management software.
Alternatively the time and date can be set manually. Press and hold the START button and then press the
EVENT buttons to enter the Set Time mode. Use the START button to select the appropriate item and use
the EVENT button to jump to the next display item.
Clearing the memory
The device memory must be cleared before every measurement series, i.e. blood pressure data form the
previous patient must not remain in the memory.
If there are existing data, the memory can be cleared with the delete function of the analysis software.
Alternatively the data can be cleared manually. Press and hold the START button for a minimum of 5
seconds until “cLr” is displayed. Within the next 5 seconds press and hold the EVENT button for at least 2
seconds to confirm the deletion of the stored measurements. The device emits a single beep to indicate that
the memory is cleared.
Preparing the ABPM 7100 - 14
Transferring patient data (ID)
The ABPM 7100 must be prepared by transferring patient data (ID) with the help of the patient management
software, so that correct data allocation is possible when it is read out after measurement. Please refer to the
respective patient management software manual for how to transfer patient data (ID) to the ABPM 7100.
Setting measurement logs
In the patient management software you can optionally choose between eleven (1-11) logs. A log serves to
set the measurement intervals. As soon as you have conducted a measurement, the log can only be
changed once you have fully deleted all data.
Manual log settings
For manual log setting, press and hold the DAY/NIGHT button while simultaneously pressing the EVENT
button. Use the START button to change the log and confirm with the EVENT button.
Setting the logs via software
To set the logs via software please refer to the respective patient management software manual.
Note •Logs1,2,10and11aresetbydefaultbutcanbechanged via the patient management
software.
•Log5issuitablefornighttimeactivities(nightshift).
•Log9isdesignatedas“Schellong-Test”.
•Log10automaticallysendsthemeasurementvaluesto your doctor’s PC via Bluetooth®.
Bluetooth® communication is not supported with the CPWS software.
•Log11isonlyavailabletoupgradedABPM7100systems in connection with HMS from
version 5.0. Blood pressure measurement intervals and the 24h PWA can be set
separately here. Please contact Welch Allyn for further information.
Log Day-Time Night-Time Measurements
per hour Audible signal Display of measured values
1 08:00 23:59 4 YES YES
00:0007:592 NO
2 08:00 22:59 4 YES YES
23:0007:591 NO
3 07:00 21:59 4 YES NO
22:0006:592 NO
4 08:00 23:59 4 YES NO
00:0007:592 NO
5 18:00 09:59 4 YES YES
10:0017:592 NO
6 07:00 23:59 4 YES YES
00:0006:592 NO
7 06:00 22:59 4 YES NO
23:0005:592 NO
8 07:00 08:59 6 YES YES
09:0023:594 YES
00:0006:592 NO
9 09:00 08:59 30 NO YES
10 08:00 07:59 30 YES NO
11 08:00 23:59 4 YES YES
00:0007:592 NO
EN

15 - Preparing the ABPM 7100
Selecting a suitable cuff
Caution
Risk of injury caused by incorrect application of the cuff.
•Thedoctormustensurethat,duetothepatient’smedical condition, the use of the device and the
cuff does not result in impaired blood circulation.
•Ifthepatientishaslimitedcognitiveabilities,the device may only be used under supervision.
•Whenusedonchildren,thedevicemustonlybeapplied with special care and under permanent
supervision.
•Itisimperativethatyouinstructthepatientinthe correct seating of the cuff.
•Informthepatientthatthecuffmayonlybeusedon the upper arm.
•Ensurethatneithertheshoulderstrapnorthecuff tubing can ever wrap around the patient’s neck.
Always place the cuff tubing under the outer clothing (even at night).
•Instructthepatienttoplacethedeviceinsuchaway that, while the cuff is inflated, the tubing is not
compressed or kinked, especially during sleep.
•Petechiae,haemorrhagesorsubcutaneoushaematomamay occur in some patients.
•Instructthepatienttoturnoffthedevice,remove the cuff, and notify the doctor if they are
experiencing pain, swelling, redness or numbness in the limb where the cuff is placed. (It is expected
that the patient may experience some mild to moderate discomfort during a blood pressure
measurement.)
Caution
Intolerances caused by the use of disinfectants.
•Washtoremoveresidues.
•Washthecuffsleevewithamilddetergentinthewashing machine at max. 30°C without spinning.
The correct cuff size is important for correct blood pressure measurement. To obtain reproducible
measurements, standardized measuring conditions are needed. Measure the circumference of the upper
arm and select the appropriate cuff:
Welch Allyn Size Number Upper Arm Circumference Cuff
09 14 – 20 cm Child
10 20 – 24 cm Small Adult
11 24 – 32 cm Adult
11L 32 – 38 cm Adult Plus
12 38 – 55 cm Large Adult
Applying the ABP Monitor and cuff
Warning
Risk of strangulation posed by the shoulder strap and cuff tubing.
•Ifthepatientishaslimitedcognitiveabilities,the device may only be used under supervision.
•Donotplacetheshoulderstrapandcufftubingaround the patient’s neck.
•Alwaysplacethecufftubingundertheouterclothing (even at night).
•Whenusedonchildren,thedevicemustonlybeapplied with special care and under permanent
supervision.
•Instructthepatienttoturnoffthedevice,remove the cuff, and notify the doctor if they are
experiencing pain, swelling, redness or numbness in the limb where the cuff is placed. (It is expected
that the patient may experience some mild to moderate discomfort during a blood pressure
measurement.)
•Measurementcanbeinterruptedatanystagebypushing any of the buttons. This automatically
deflates the cuff and the device can be removed.
Preparing the ABPM 7100 - 16
W a r n in g
Poor circulation caused by continuous cuff pressure.
•Donotkinktheconnectingtubing.
•Ifthepatienthaslimitedcognitiveabilities,the device may only be used under supervision.
•Ensurethecorrectplacementoftheshoulderstrapand cuff tubing.
•Alwaysplacethecufftubingundertheouterclothing (even at night).
•Whenusedonchildren,thedevicemustonlybeapplied with special care and under permanent
supervision.
•Instructthepatienttoturnoffthedevice,remove the cuff, and notify the doctor if they are
experiencing pain, swelling, redness or numbness in the limb where the cuff is placed. (It is expected
that the patient may experience some mild to moderate discomfort during a blood pressure
measurement.)
W a r n in g
Placement and inflation of the cuff over a wound may lead to further injuries.
Placement and inflation of the cuff on any limb with an intravascular access or under
intravascular treatment or an arteriovenous (A-V) shunt may lead to temporary interruption of
circulation and therefore to further patient injury.
Placement and inflation of the cuff on the arm at the side of a breast amputation may lead to
further injury.
•Examinethepatientforwounds,bandages,etc.
•Questionthepatientregardingprevioustreatments.
•Observethepatientclosely.
•Instructthepatienttoturnoffthedevice,remove the cuff, and notify the doctor if they are
experiencing pain, swelling, redness or numbness in the limb where the cuff is placed. (It is expected
that the patient may experience some mild to moderate discomfort during a blood pressure
measurement.)
Warning
In very rare cases materials used for and on the cuff may cause allergic reactions.
•
Do not use the cuff on patients with a known hypersensitivity to epoxy resin.
Caution
Intolerances caused by the use of disinfectants.
•Washtoremoveresidues.
•Washthecuffsleevewithamilddetergentinthewashing machine at max. 30°C without spinning.
Caution
Risk of injury caused by incorrect application of the cuff.
•Thedoctormustensurethat,duetothepatient’smedical condition, the use of the device and the
cuff does not result in impaired blood circulation.
•Ifthepatienthaslimitedcognitiveabilities,the device may only be used under supervision.
•Whenusedonchildren,thedevicemustonlybeapplied with special care and under permanent
supervision.
•Itisimperativethatyouinstructthepatientinthe correct seating of the cuff.
•Informthepatientthatthecuffmayonlybeusedon the upper arm.
•Ensurethatneithertheshoulderstrapnorthecuff tubing can ever wrap around the patient’s neck.
Always place the cuff tubing under the outer clothing (even at night).
•Instructthepatienttoplacethedeviceinsuchaway that, while the cuff is inflated, the tubing is not
compressed or kinked, especially during sleep.
•Petechiae,haemorrhagesorsubcutaneoushaematomamay occur in some patients.
•Instructthepatienttoturnoffthedevice,remove the cuff, and notify the doctor if they are
experiencing pain, swelling, redness or numbness in the limb where the cuff is placed. (It is expected
that the patient may experience some mild to moderate discomfort during a blood pressure
measurement.)