Welch Allyn ABPM 7100 Directions For Use Manual
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
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Table of contents - 3
Table of contents
Symbols 4
Introduction 5
Preliminary note 5
About these directions for use 5
Clinical trials 5
CE Mark 5
Content 6
Direction for use 6
Intended use 6
Indications for use 6
Improper use 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 and disinfection 21
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
Patient Information - operation of the ABPM 7100 31
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4 - Symbols
Symbols
Documentation symbols
WARNING The warning statement
identifies an immediate threat. Nonadherence may lead to the most severe
injuries and to death
CAUTION The caution statement
identifies a possible hazard. Nonadherence 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
Introduction - 5
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.
Please refer to the CPWS directions for use for software operating instructions.
For the upgrades please refer to the respective directions 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 trials
The blood pressure measuring device ABPM 7100 fulfills the requirements of the ESH (European Society of
Hypertension).
The blood pressure measuring device ABPM 7100 fulfills the requirements of the BHS (British Hypertension
Society).
CE Mark
The ABPM 7100 fulfills the requirements of the following directives:
Directive 93/42/EEC (MDD)
Directive 1999/5/EC (R&TTE)
Directive 2011/65/EU (RoHS)
The ABPM 7100 bears the CE mark.
6 - Direction for use
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.
Only use accessories approved and distributed by the manufacturer and Welch Allyn.
Check the accessories regarding the manufacturer’s information before first use.
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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 adult 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.
Indications for use
The ABPM 7100 is an automated microprocessor controlled ambulatory blood pressure monitor (ABPM)
which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual
adult patient (in the patient’s environment) for a session which may last 24 hours.
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.
It is used with a standard cuff for blood pressure measurement.
It is used in those 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.
Improper use
The ABPM 7100 may not be used for any purpose other than for the blood pressure monitoring
procedures described here!
Due to the strangulation risk posed by tubing and cuff, the ABPM 7100 may not be used on patients
with limited cognitive abilities, patients under anesthetics and must not be placed within reach of
unsupervised children.
The ABPM 7100 must not be used on neonates and children under the age of 3 years. The device has
not been tested with pregnant women, including preeclamptic patients.
The ABPM 7100 must not be used for blood pressure monitoring purposes during surgeries.
The ABPM 7100 is not intended for alarm-triggering monitoring purposes in intensive care units.
Product description - 7
Essential Performance
The main performance features are defined as blood pressure measurement with:
Error tolerances of the pressure gauge and measurement results are within required limits (IEC
80601-2-30).
Maximum change value in blood pressure determination is as specified in IEC 80601-2-30.
Cuff pressurization remains within specified limits (IEC 80601-2-30).
An error is issued in the event that successful blood 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.
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Side effects of 24-hour blood pressure monitoring
24-hour blood pressure monitoring is a commonly practiced, accepted and valued measurement
technique, used in daily diagnostics and treatment monitoring.
When considering 24-hour blood pressure monitoring, always check whether the patient displays
coagulation disorders or is being treated with anticoagulants. As with occasional blood pressure
measurements, petechial haemorrhage (bleeding) 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.
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Product description
Introduction
The ABPM 7100 System consists of two main components:
The ABPM 7100 with cuffs and accessories
Patient management software for the doctor to evaluate 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.
8 - Product description
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.
Product description - 9
Audible signals
Individual or multiple beeps of audible signals are used. The following table explains the meaning of the
beeps:
1 beep
Switching ON/OFF
Starting and ending a measurement (except at night intervals)
Removal of the interface cable
Establishing and ending Bluetooth® communication
Measurement errors
3 beeps
System errors
Continuous beeps
Severe system errors (e.g. cuff pressure is higher than 15 mmHg for longer than
10 seconds outside the measurement)
Combined beeps
Manual deletion of measurement, 1 beep followed by 5 beeps 2 seconds later
Cuff connection
The cuff connection is located at the top of the ABPM 7100 casing.
The cuff is connected to the ABPM 7100 via a metal connector.
Attention
Measurement errors
The cuff connection must always engage with an audible “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.
10 - Product description
PC Interface Cable Port
The connecting port for the PC interface cable is located at the bottom of the ABPM 7100 casing.
The red dot on the plug must align with the red dot on the port before plugging.
To disconnect, pull on the knurled ring of the connector.
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
Preparing the ABPM 7100 - 11
Preparing the ABPM 7100
Safety instructions
Warning
Risk of strangulation posed by the shoulder strap and cuff tubing.
If the patient has limited cognitive abilities, the device may only be used under supervision.
Do not place the shoulder strap and cuff tubing around the patient’s neck.
Always place the cuff tubing under the outer clothing (even at night).
Instruct the patient to switch off and remove the device immediately and to inform the doctor in the
event of experiencing any pain.
Measurement can be interrupted at any stage by pushing any of the buttons. This deflates the cuff
and the device can be removed.
Cautio n
Risk of injury caused by incorrect application of the device.
The doctor must ensure that, due to the patient’s medical condition, the use of the device does not
result in impaired blood circulation in the arm.
If the patient has limited cognitive abilities, the device may only be used under supervision.
While it is still attached to a patient, the device may never be connected to a PC or other device.
Instruct the patient to place the device in such a way that, while the cuff is inflated, the tubing is not
compressed or kinked, especially during sleep.
Petechiae, haemorrhages or subcutaneous haematoma may occur in some patients.
Instruct the patient to switch off and remove the device immediately and to inform the doctor in the
event of experiencing any pain.
Cautio n
Risk of injury caused by incorrect application of the cuff.
The doctor must ensure that, due to the patient’s medical condition, the use of the device does not
result in impaired blood circulation in the arm.
If the patient is has limited cognitive abilities, the device may only be used under supervision.
It is imperative that you instruct the patient in the correct seating of the cuff.
Inform the patient that the cuff may only be used on the upper arm.
Ensure that neither the shoulder strap nor the cuff tubing can ever wrap around the patient’s neck.
Always place the cuff tubing und the outer clothing (even at night).
Instruct the patient to place the device in such a way that, while the cuff is inflated, the tubing is not
compressed or kinked, especially during sleep.
Petechiae, haemorrhages or subcutaneous haematoma may occur in some patients.
Instruct the patient to switch off and remove the device immediately and to inform the doctor in the
event of experiencing any pain.
Cautio n
Intolerances caused by the use of disinfectants.
Wash to remove residues.
Wash the cuff sleeve with a mild detergent in the washing machine at max. 30°C without spinning.
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