Welch Allyn ABPM 6100 Hardware manual

ABPM 6100 Hardware Manual
Regulatory Affairs
Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath,
Republic of Ireland
0297
DIR 80012720 Ver. F
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY
13153 USA
www.welchallyn.com
ABPM 6100 Hardware Manual
Copyright
© Copyright 2014, Welch Allyn. All rights are reserved. 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. Welch
Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of
the product, that may result from failure to use this product in accordance with the
instructions, cautions, warnings, or statement of intended use published in this manual.
Unauthorized copying of this publication may not only infringe copyright but also reduce the
ability of Welch Allyn to provide accurate and up-to-date information to users and operators
alike.
®
®
®
Welch Allyn , CardioPerfect Workstation and SpiroPerfect are registered trademarks of
Welch Allyn.
Software in this product is Copyright 2014, Welch Allyn. All rights are reserved. The
software is protected by United States of America copyright laws and international treaty
provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy
of the software provided on the original distribution medium. The software may not be
copied, decompiled, reverse-engineered, disassembled or otherwise reduced to humanperceivable form. This is not a sale of the software or any copy of the software; all right, title
and ownership of the software remains with Welch Allyn.
The information contained in this manual is subject to change without notice.
All changes will be in compliance with regulations governing manufacture of medical
equipment.
User responsibility
This product is designed to perform in conformity with the description thereof contained in
this manual and accompanying labels and inserts, when assembled, operated, maintained
and repaired in accordance with the instructions provided. A defective product should not
be used. Parts that are broken, plainly worn, missing or incomplete, distorted or
contaminated should be replaced immediately. Should any repair or replacement become
necessary, we recommend that service be performed at the nearest approved service
center. The user of the product shall have the sole responsibility for any malfunction, which
results from improper use, faulty maintenance, improper repair, damage or alteration by
anyone other than Welch Allyn or their authorized service personnel.
Accessories
The Welch Allyn warranty can only be honored if you use Welch Allyn approved
accessories and replacement parts.
Caution
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Use of accessories other than those recommended by Welch Allyn may
compromise product performance.
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ABPM 6100 Hardware Manual
Warranty, Service, and Spare Parts
Warranty
All repairs on products under warranty must be performed or approved by Welch Allyn.
Unauthorized repairs will void the warranty. In addition, whether or not covered under
warranty, any product repair shall exclusively be performed by Welch Allyn certified service
personnel.
Assistance and Parts
If the product fails to function properly or if assistance, service, or spare parts are required,
contact the nearest Welch Allyn Technical Support Center.
USA
Latin America
European Call
Center
United Kingdom
France
Germany
Netherlands
1-800-535-6663
(+1) 305-669-9003
(+353) 46-90-67790
Canada
South Africa
Australia
1-800-561-8797
(+27) 11-777-7555
(+61) 2-9638-3000
(+44) 207-365-6780
(+33) 1-55-69-58-49
(+49) 695-098-5132
(+31) 202-061-360
Singapore
Japan
China
Sweden
(+65) 6419-8100
(+81) 42-703-6084
(+86) 21-6327-9631
(+46) 85-853-65-51
Before contacting Welch Allyn it is helpful to attempt to duplicate the problem and to check
all accessories to ensure that they are not the cause of the problem.
When calling, please be prepared to provide:





Product name and model number and complete description of the problem
The serial number of your product (if applicable)
The complete name, address and phone number of your facility
For out-of-warranty repairs or spare parts orders, a purchase order (or credit card)
number
For parts order, the required spare or replacement part number(s)
Repairs
If your product requires warranty, extended warranty, or non-warranty repair service, please
call first the nearest Welch Allyn Technical Support Center. A representative will assist you
troubleshooting the problem and will make every effort to solve it over the phone, avoiding
potential unnecessary return.
In case the return cannot be avoided, the representative will record all necessary
information and will provide a Return Material Authorization (RMA) number, as well as the
appropriate return address. A Return Material Authorization (RMA) number must be
obtained prior to any return.
Note
Welch Allyn does not accept returned products without an RMA.
Packing Instructions
If you have to return goods for service, follow these recommended packing instructions:
 Remove all hoses, cables, sensors, power cords, and ancillary products (as
appropriate) before packing, unless you suspect they are associated with the problem.
 Wherever possible use the original shipping carton and packing materials.
 Include a packing list and the Welch Allyn Return Material Authorization (RMA) number.
It is recommended that all returned goods be insured. Claims for loss or damage to the
product must be initiated by the sender.
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ABPM 6100 Hardware Manual
Limited Warranty Statement
Welch Allyn, Inc. warrants that the Welch Allyn CardioPerfect Workstation computer based
product you have purchased meets the labelled specifications of the Product and will be
free from defects in materials and workmanship that occur within 1 year after the date of
purchase. Accessories used with the Product are warranted for 90 days after the date of
purchase.
The date of purchase is: 1) the date specified in our records, if you purchased the Product
directly from us, 2) the date specified in the warranty registration card that we ask you to
send to us, or 3) if you don’t return the warranty registration card, 120 days after the date on
which the Product was sold to the dealer from whom you bought the Product, as
documented in our records.
This warranty does not cover damage caused by: 1) handling during shipping, 2) use or
maintenance contrary to labelled instructions, 3) alteration or repair by anyone not
authorized by Welch Allyn, and 4) accidents.
You assume all responsibility for use of the Product with any hardware or software that
does not meet the system requirements described in the Product documentation.
If a Product or accessory covered by this warranty is determined to be defective because of
defective materials, components, or workmanship, and the warranty claim is made within
the warranty period described above, Welch Allyn will, at its discretion, repair or replace the
defective Product or accessory free of charge.
You must obtain a return authorization from Welch Allyn to return your Product before you
send it to Welch Allyn’s designated service center for repair.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. WELCH ALLYN'S
OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT
OF PRODUCTS CONTAINING A DEFECT. WELCH ALLYN IS NOT RESPONSIBLE FOR
ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A PRODUCT
DEFECT COVERED BY THE WARRANTY.
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ABPM 6100 Hardware Manual
Table of contents
1.
OVERVIEW ............................................................................................................................... 6
2.
ABPM 6100 MONITOR ........................................................................................................... 10
2.1
2.2
3.
Introduction ........................................................................................................................ 10
Operation ........................................................................................................................... 11
INTERFACE ............................................................................................................................ 13
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
Preliminary Directive.......................................................................................................... 14
Prior to Hook-up ................................................................................................................ 14
Sizing ................................................................................................................................. 14
Traditional Cuff Placement ................................................................................................ 15
Sleeve Cuff Placement ...................................................................................................... 16
Office Readings ................................................................................................................. 17
Regular Runs ..................................................................................................................... 17
Data ................................................................................................................................... 18
4.
MAINTENANCE AND CLEANING ......................................................................................... 19
5.
CALIBRATION CHECK .......................................................................................................... 20
6.
SPECIFICATIONS .................................................................................................................. 21
7.
CLASSIFICATION .................................................................................................................. 22
8.
DISCARDING THE EQUIPMENT ........................................................................................... 22
9.
TROUBLESHOOTING AND ERROR CODES ....................................................................... 23
9.1
9.2
10.
Error Codes ....................................................................................................................... 23
Troubleshooting ................................................................................................................. 24
GUIDANCE AND MANUFACTURER’S DECLARATIONS ................................................ 25
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ABPM 6100 Hardware Manual
1. Overview
The purpose of this manual is to provide an overview of information that you will need to
safely and effectively use the ABPM 6100 monitor. Information about the CardioPerfect
Workstation Software is available in the CardioPerfect Workstation software manual. Make
sure that you familiarize yourself with all of the safety precautions listed in this chapter
before attempting to use either device or the software.
Intended Use
PROPER USE OF THE ABPM 6100 MONITORS:
1. The ABPM monitors are intended for use by a trained medical practitioner.
Interpretation of blood pressure measurements should always be performed by a
physician.
2. The reliability of all the monitors and the software depend upon conformance with the
operation and maintenance instructions in this manual.
3. The ABPM 6100 monitors are designed for use with patients with normal sinus rhythms.
4. Measurement accuracy for the ABPM 6100 monitors may be affected by position of the
subject, physical conditions, movement, and use outside of the operating instructions
contained in this manual.
Conventions
Caution: consult accompanying documents
Identifies information within the manual to avoid injury
Serial Number
Defibrillation-proof type BF applied part
Meets essential requirements of European Medical Device Directive
93/42/EEC
Manufacturer
IPXØ
No protection against the ingress of liquids
Identifies the battery
Do not dispose of this product as unsorted municipal waste. Prepare
this product for reuse or separate collection as specified by Directive
2002/96/EC of the European Parliament and the Council of the
European Union on Waste Electronic and Electrical Equipment
(WEEE). If this product is contaminated, this directive does not
apply.
For more specific disposal information, see www.welchallyn.com/
weee, or contact Welch Allyn Customer Service.
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EMC Framework of Australia
Recycle
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ABPM 6100 Hardware Manual
Safety and Effectiveness Warnings and Cautions
Safety and Effectiveness Warnings
Make sure that you are familiar with all Safety and Effectiveness considerations before
using the ABPM 6100 monitor.
IMPORTANT WARNINGS
The following warnings apply to the ABPM 6100 Ambulatory Blood Pressure Monitors:
Warning
Patient Injury risk. Do not place the cuff on any area where
circulation is compromised. Instruct the patient to remove the cuff
immediately and notify the doctor if they are experiencing pain,
swelling, redness or numbness in the limb where the cuff is placed
as this may indicate compromised circulation.
The ABPM 6100 has not been designed for use with high
frequency (HF) surgical equipment and does not protect against
hazards to the patient.
Ensure the location of the ABPM 6100 provides maximum
separation away from all sources of high-frequency energy.
DO NOT use the ABPM 6100 monitor in the presence of flammable
anaesthetics due to risk of explosion.
DO NOT immerse the ABPM 6100 monitor in any fluid, place any
fluid on the monitor, or attempt to clean either monitor with liquid
detergents or cleaning agents. If any of these instances occurs,
return the unit to an authorized Welch Allyn Service Center. The
ABPM 6100 may be cleaned with a damp cloth only.
DO NOT remove the ABPM 6100 covers. Neither unit contains any
serviceable parts.
DO NOT use the monitor if it has failed any diagnostic self-test.
DO NOT use the unit if it displays a pressure greater than zero
when no cuff is attached. This could lead to inaccurate
measurements.
DO NOT attach the cuff to a limb being used for intravenous
infusions. This may cause the infusion to be blocked and cause the
patient harm.
DO NOT substitute any component for those supplied by Welch
Allyn.
DO NOT attempt to repair the unit yourself. Repairs should be
performed only by authorized Welch Allyn Service Centers
DO NOT attach the cuff to a patient while the PC Serial Connector
is attached to the unit.
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ABPM 6100 Hardware Manual
Caution
The ABPM 6100 is intended to be used as an ambulatory blood
pressure recorder that is sent home with the patient to record their
blood pressure over a 24 hour period. It is used to gather trending
information in non-critical settings.
It is not intended to provide clinicians with real time monitoring of
patients in an ER or critical care environment.
The ABPM 6100 monitors are not intended for use on pregnant
women or neonates.
The ABPM 6100 units may not yield accurate blood pressure
measurements for patients experiencing moderate to severe
arrhythmias.
Check to ensure that the operation of the unit does not result in
prolonged impairment of the patient’s circulation. Instruct the patient
to manually remove the cuff if it fails to deflate within three minutes.
Avoid compression or restriction of pressure tubes.
The ABPM 6100, the cuff and tubing are defibrillator protected. The
ABPM 6100 has no specific precautions during defibrillation, and
defibrillation has no effect on the ABPM 6100 monitor.
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ABPM 6100 Hardware Manual
2. ABPM 6100 Monitor
2.1
Introduction
The ABPM 6100 Unit is worn by the patient in a belt or shoulder strap and is connected to a
cuff, which is wrapped around the non-dominant arm. ABPM 6100 inflates the cuff at preprogrammed intervals throughout the day and measures blood pressure using the
oscillometric method, which senses the cessation of pressure waves in the artery when
occluded by pressure in the cuff. Heart rate can also be measured using the frequency of
pressure waves.
Blood pressure measurements made by the ABPM 6100 are equivalent to those made by a
trained observer using the cuff/stethoscope auscultation method within the limits prescribed
by the American National Standard, Electronic or Automated Sphygmomanometers.
To get the most out of the ABPM 6100, you should read this section of the manual
thoroughly. You will also need to read and understand the CardioPerfect Workstation
software manual to properly interface the ABPM 6100 monitor with the software.
Checklist
Check to make sure that the ABPM 6100 package contains the following:
- ABPM 6100 Monitor, PC Interface Cable, Belt and Shoulder Strap,
- Warranty Card, Patient Diary and Cuff Anchors pads
- Adult Size Cuff
- 4 AA Batteries
- CardioPerfect Workstation Software Manual CD
- Monitor Pouch
Caution
Substitution of a component different from that supplied might
result in measurement error!
Remember to fill out your warranty registration card and send it to Welch Allyn as soon as
possible. Report any damaged or missing components to your authorized Welch Allyn
representative.
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ABPM 6100 Hardware Manual
2.2
Operation
This section provides a brief overview of the ABPM 6100 unit, how to load the batteries, and
the unit controls.
The ABPM 6100 features a simple design. One Start/Stop button functions as the primary
control. The LCD (liquid crystal display) displays easy-to-read information. The
CardioPerfect Workstation Software allows you to program the unit before the study and
retrieve data after the study. A single air hose connector allows you to connect the cuff to
the unit.
The Start/Stop button allows you to perform the following functions:
- Turn the unit On when it is Off.
- Put the unit into Study Mode and take a reading when the unit is in Normal Mode. The
time will flash on the LCD when the unit is in Normal Mode.
- Turn the unit Off from Normal or Study mode when the button is pressed and held until
the unit beeps five times (approximately five seconds)
- Initiate a reading when the unit is in Study Mode.
- Abort a reading and deflate the cuff if pressed when the unit is taking a reading.
On the back of the ABPM 6100 monitor, a label lists the model and serial number of the unit.
The first four digits of the serial number correspond to the year that the unit was
manufactured. The battery compartment is on the back of the unit. The connector on the
bottom of the unit allows you to connect the unit to a PC using the PC Interface Cable.
Batteries
The ABPM 6100 monitor requires 2 AA batteries. Batteries are installed into the ABPM
6100 unit in the battery bay located at the back of the unit. If rechargeable batteries are
used, please refer to the manufacturer’s guidelines for safe use and adequate maintenance.
When batteries are properly loaded and first installed, the unit will display the following:
- Incrementing dashes for 2 seconds.
- Two sets of numbers, the first set of three being the Software Version
- Battery voltage displayed for 2 seconds (prior to the voltage, the letter “b” will present)
- Three quick audible beeps.
- The number of BP readings (if any) in memory along with a flashing printer symbol for 3
seconds (the number of readings may not be displayed if the batteries were removed
before the unit was turned off)
- One long audible beep.
- Displays flashing time for 20 seconds (after 20 seconds the units turns itself off and
goes into Sleep Mode to conserve battery life)
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At this point the unit will be ready to upload a BP Study. When the unit is turned on
subsequently, the unit will display the following:
- Three quick audible beeps.
- The number of BP readings (if any) in memory along with a flashing printer symbol for 3
seconds.
- One long audible beep.
- Displays flashing time for 20 seconds (after 20 seconds the units turns itself off and
goes into Sleep Mode to conserve battery life)
The LCD Display
The LCD displays the following information depending upon the state that the unit is in:
- The time is displayed whenever the unit is in Normal Mode and ready for an action.
- A sun symbol is displayed whenever the buzzer is on (usually during the day).
- A Crescent Moon symbol is displayed when the buzzer is off (usually during
programmed sleeping periods).
- A clock is displayed whenever the unit is in Study Mode.
- A battery symbol is displayed whenever the battery voltage is low and the batteries
need to be replaced.
- A printer symbol indicates that the unit contains readings in the memory.
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3. Interface
This section describes how to connect the ABPM 6100 monitor to your PC and how to set
up patients for monitoring sessions.
To set up the ABPM 6100 for communication to your PC for the first time:
Windows XP
Windows 7/ Windows 8
1. Right-click on My Computer.
1. Right-click on Computer.
2. Select Properties.
3. Click the Hardware tab.
4. Click the Device Manager.
2. Select Properties.
5. Double-click Ports (COM & LPT)
6. Plug the ABPM 6100 PC Interface Cable
into a USB port on your PC. Allow
Windows to install the driver.
4. Double-click Ports (COM & LPT)
5. Plug the ABPM 6100 PC Interface Cable into a
USB port on your PC. Allow Windows to install the
driver.
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3. Click the Device Manager.
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ABPM 6100 Hardware Manual
To configure Welch Allyn CardioPerfect Workstation for use with the recorder:
1. Start Welch Allyn CardioPerfect Workstation.
2. In the File menu, click Settings and click Ambulatory blood pressure.
3. Click the Advanced tab.
4. Select device.
5. Set the COM-port number to the number of the serial port to which the ABP recorder is
connected.
6. Click OK to save the settings.
3.1
Preliminary Directive
Advise the patient to:
- Wear a loose fitting blouse or shirt.
- Avoid wearing long sleeved sweaters or dresses during monitoring period.
- Avoid swimming, showering, or bathing during monitoring.
- Avoid operating heavy equipment or power tools, as vibrations may functionally disrupt
the monitor.
3.2
Prior to Hook-up
Before hooking the ABPM 6100 unit up to the patient, make sure you have performed the
following tasks:
- Be sure the patient name and ID are on the diary and logged separately to avoid
confusion with other patient data.
- Make sure that the ABPM 6100 monitor contains new or charged batteries.
- For new studies, make sure that all old data has been downloaded to the CardioPerfect
Workstation Software and the ABPM 6100 monitor’s memory has been cleared out.
- Make sure that the proper Study parameters have been written from the CardioPerfect
Workstation Software to the unit.
- Seat the patient comfortably. If the patient has long sleeves, have the patient remove
his or her shirt. Ask the patient which is the non-dominant arm. You will place the cuff
on this arm.
3.3
Sizing
Since correct cuff sizing is vital to the accuracy of monitoring data, make sure that you read
this section carefully and understand all of the information contained herein before sizing
the cuff to the patient.
USING THE CUFF RANGE MARKS
Each cuff has two range marks. To size using the range marks, wrap the cuff around the
patient’s non-dominant arm. If the edge of the cuff falls within the range marks, the cuff is
the correct size for the patient. If the cuff edge does not fall within the range marks, try a
different size cuff.
USING THE SIZING TABLE
For proper cuff selection, find the circumference of the patient’s upper arm and refer to this
cuff sizing chart.
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Arm Circumference
Cuff Size
Reusable sleeve cuffs
Pediatric Cuff
NA
Part 101340
18-27 cm
Part 101341
25-35 cm
Part 101342
33-40 cm
Part 101343
39-46 cm
Small Adult Cuff
Adult Cuff
Adult Plus Cuff
Large Adult Cuff
3.4
Traditional Cuff Placement
Proper cuff placement is very important to achieve accurate blood pressure measurements.
Follow these instructions to ensure the cuff is accurately placed on the patient.
Traditional cuff
1. Wrap the cuff snugly around the patient’s non-dominant arm as shown in the picture,
making sure that the air hose leading from the cuff is not crimped or damaged. The cuff
may be worn over a thin shirt without compromising the readings.
2. Attach an adhesive cuff anchor to the clear tab on the cuff, and fasten the cuff anchor to
the patient.
Note: Make sure that the parameters have been written to the ABPM 6100 monitor
before proceeding. The monitor should be in sleep mode.
3. Attach the tubing from the ABPM 6100 monitor to the cuff tubing and insert the ABPM
6100 monitor into the monitor pouch. Attach the pouch to the shoulder strap or the belt,
depending upon which is more comfortable to the patient. Be sure to allow enough
slack for the patient to move comfort ably.
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3.5
Sleeve Cuff Placement
Using an incorrect cuff size could result in erroneous and misleading blood pressure
measurements.
Sleeve cuff
Step 1: To determine the correct cuff size for your patient, follow these simple steps:
1. To find the right sized cuff, wrap the cuff around the patient’s upper arm without
sliding the arm through the sleeve.
2. Use the color-coded RANGE indicator on the inside of the cuff and the bold INDEX
marker to check that the arm circumference falls within the cuff range.
3. If the arm is within range, this cuff size is correct for your patient. If the
measurement is outside the RANGE indicator, select a new cuff size as indicated
by color.
Step 2: Applying the Cuff
1. To apply the Welch Allyn ABPM 6100 cuff, simply slide the sleeve up the patient’s
arm, ensuring the color size indicator is at the top of the cuff. The cuff should be
midway between the elbow and shoulder.
2. Be sure the ARTERY indicator is over the patient’s brachial artery, between the
biceps and triceps muscles (see illustration showing left arm placement).
3. Wrap the cuff snugly around the patient’s upper arm.
4. Take the initial BP reading and ensure hookup is working.
5. Refer to figures 1, 2 and 3 on inside flap for an illustrated overview.
Step 3: Prepare the Patient
1. Preparing the patient is the most important step in obtaining an accurate, reliable
blood pressure measurement.
2. Review the following instructions with your patient:

Avoid excess movement during readings

Relax the instrumented hand, slightly away from the body

Avoid hand movement
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ABPM 6100 Hardware Manual
3.6

Avoid flexing muscles during the reading

Do not remove the cuff between readings
Office Readings
Once the ABPM 6100 monitor has been properly attached to the patient and the PC
interface cable has been removed from the unit, it is important and necessary to perform
office readings in order to make sure that the unit is functioning properly and does not
cause discomfort to the patient. The ABPM 6100 monitor will not begin regular runs until at
least one manually initiated reading has been taken. Follow these instructions to perform an
Office Reading:
1. If the unit is in Sleep Mode (no display on the LCD), press the Start/Stop button to
“wake” the unit.
2. Press the Start/Stop button again to initiate a manual reading. This will cause the cuff to
inflate and a reading to be taken.
3. Record the readings that are taken in the office as office readings into the patient diary,
so that information can be taken into account in the analysis of the study. This is also a
good opportunity to instruct the patient about the use of the patient diary.
If the Start button is disabled when the parameters are written to the unit (thus disallowing
initiation of manual readings), the ABPM 6100 monitor still allows you to manually initiate
measurement for up to 30 minutes after parameters have been written to the unit and the
unit has been “woken” from Sleep Mode. This allows you to initiate manual office readings
even if you do not wish the patient to be able to initiate readings.
3.7
Regular Runs
Once at least one manual office reading has been taken, regular readings will initiate based
upon the interval configured for the first time period.
BEFORE THE PATIENT LEAVES
Make sure of the following before the patient leaves the office:
 The belt or shoulder strap and pouch are positioned comfortably.
 The Start/Stop button is accessible to the patient. (Even if the Start button is disabled in
the Study Parameters, the Start/Stop button will still allow the patient to cancel a
reading.)
 The ABPM 6100 monitor is concealed according to the patient’s wishes.
 Remember the patient’s comfort and ability to perform normal tasks can significantly
impact the relevance of monitoring data.
 If the display is on, briefly review with the patient how to read the data.
 Explain to the patient the kind of information required in the Patient Diary.
 If the Start button is enabled, explain to the patient that he or she has the option to
initiate readings using the Start/Stop button.
OTHER INSTRUCTIONS FOR PATIENTS
The patient should also be advised of the following:
 Pressing the Start/Stop button during a reading will cancel that reading and deflate the
cuff regardless of whether the Start button is set to On or Off in the Study Parameters.

Advise the patient to undress carefully at bedtime, using caution not to disconnect the
hose from the monitor.
 Placing a pillow over the monitor during sleep will reduce any electrostatic hum from the
ABPM 6100 unit.
 All data is stored internally after deactivation.
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PATIENT DO’S AND DON’TS:
Finally, familiarize the patient with the following list of do’s and don’ts:
Do:
 Wear a loose fitting blouse or shirt.
 Record time, symptom/mood and activity/position in the patient diary.
 Activate a reading (if the Start/Stop button is activated) at the first sign of symptoms.
 Remain motionless during readings.
 Keep vehicle driving and travel to a minimum.
 Bring diary upon return.
Don’t:
 Remove the cuff.
 Get the monitor wet.
 Use power tools or heavy equipment during a reading.
 Remove the batteries from the unit.
 Wear long-sleeved sweaters or dresses during monitoring period.
 Swim, shower, or bathe during monitoring.
 Operate heavy equipment or power tools, as vibrations may functionally disrupt the
monitor.
3.8
Data
After the ABPM 6100 monitor is disconnected from the patient, you will need to reconnect
the monitor to the PC in order to read data from the unit. To reattach the monitor to the PC,
simply locate the monitor (smaller) end of the PC Interface Cable and insert it into the
communications port located at the bottom of the unit (the PC end of he PC Interface Cable
should still be attached to the PC).
Reading Data from the Unit
Whenever data is contained in the unit, it can be read from the unit into the ABPM 6100
software. The CardioPerfect Workstation software will then allow you to view the data and
configure reports. See the CardioPerfect Workstation software manual for more information.
To read data from the unit:
1. Make sure that the ABPM 6100 monitor is properly connected to the PC.
2. Open the CardioPerfect Workstation software.
3. Select the Patient Study that you wish to read data into by clicking the representative
date under the appropriate patient name. If no Patient Study has been created yet,
create a Patient Study by following the instructions in the Creating a New Patient Study
section of the CardioPerfect Workstation software manual.
4. Follow the instructions in the CardioPerfect Workstation Software Manual chapter 2.3
5. Within a few seconds, the data will be retrieved from the unit. If the Patient ID in the
Unit does not match the Patient ID in the CardioPerfect Workstation software Patient
Study, a message will appear stating, “Patient ID in unit and study do not agree. Use ID
in unit?” Select Yes to use the Patient ID currently stored in the unit; select No to use
the Patient ID in the CardioPerfect Workstation software.
The data from the unit will now be stored in the CardioPerfect Workstation software. If you
receive an error message when you try to read data from the unit, make sure the PC
Interface Cable is properly attached to both the monitor and the PC and repeat the Read
Data from Unit command.
See the CardioPerfect Workstation software manual for instructions on using the software
and the data handling and reporting options it offers.
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4. Maintenance and Cleaning
Preventative maintenance should be routinely performed to ensure the safe and efficient
operation of the ABPM 6100 monitor. In addition, the monitor should be cleaned after each
use.
Maintenance
The following inspections of the ABPM 6100 unit should be performed on a regular basis:
 The PC connection cable should be inspected for any cracks, exposed wires or other
damage.
 The monitor itself should be visibly inspected for any signs of damage.
 Pneumatic tubing should be inspected for any cracks, fraying, or kinks.
 Do not remove any covers or break the warranty seal while inspecting the unit.
If any signs of damage are detected, do not use the ABPM 6100 monitor. It should be sent
to an authorized Welch Allyn service center. See the Service and Warranty section of this
manual for a list of authorized Welch Allyn service centers.
Cleaning
CLEANING THE ABPM 6100 UNIT
IMPORTANT: The ABPM 6100 cannot be sterilized. DO NOT immerse the
monitor in any fluid or use liquid detergents, cleaning agents, or
solvents to clean it. If the unit is immersed in any liquid, do not use the
unit again. The unit should be sent to an authorized Welch Allyn service
center.
The ABPM 6100 unit should be cleaned after every use. Use a soft, damp cloth to remove
any dirt and dust from the unit.
CLEANING AND DISINFECTING THE CUFF
1. Medical Disinfectant
Spray
The cuff may be sprayed with a mild disinfectant solution
®
®
(e.g. Cidezyme , ENZOL , or 10% bleach solution. Follow
the direction on the solution), rinsed with distilled water, and
line dry. Ensure that no liquid enters the bladder tubing.
2. Medical Disinfect Wipe
Use a mild disinfectant wipe (e.g. Sani-Cloth ) and
thoroughly wet cuff surface and line dry.
3. Machine Wash
Remove bladder to machine wash the cuff shell. Machine
wash warm (50 - 130° F, 10 - 54° C) with a mild detergent
and line dry.
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5. Calibration Check
Welch Allyn recommends that the calibration of the ABPM 6100 monitor be verified annually
by the user using the following procedure:
1. With the ABPM 6100 unit already powered up, remove one of the AA batteries from the
battery compartment. Then immediately replace the battery back in its proper
orientation, which will result in the unit to start the power up cycle.
2. While the LCD is displaying dashes, press and hold down the Start/Stop button. The
unit will display the software version, the battery voltage, followed by a click as the
valves are closed. When the process is finished, a pressure value will be displayed on
the LCD and the unit is ready to have the calibration checked.
3. Disconnect the ABPM 6100 monitor cuff assembly from the unit
4. Attach the appropriate end of ABPM 6100 Y-connector (Welch Allyn Part #6100-25) to
the monitor. Attach a cuff to the appropriate end of the Y-connector, and wrap around a
suitably sized can or bottle. This acts as the reservoir for the unit. Connect the third leg
1
of the Y-connector to a high quality, known pressure standard . Refer to the calibration
figure below for a sketch of the test set up.
5. Pressurize gauge to 250 mmHg and compare against pressure standard (see Note
below). If the unit does not meet the required calibration, unit needs to be returned to
Welch Allyn for calibration or repair.
6. Bleed pressure down no faster than 10 mmHg per second, stopping to check the
pressure at 250, 200, 150, 100, and 50 mmHg
7. When finished, remove one of the AA batteries from the battery compartment. Then
immediately replace the battery back in its proper orientation, which will cause the unit
to start the power up cycle.
Cuff Wrapped Around Cylinder
Typical Office Manometer
Attach to Unit
Note: Your ability to measure the accuracy of the ABPM 6100 depends upon the sensitivity
of the pressure standard you use for the calibration procedure.



If using a manometer (mercury column or aneroid gauge) rated at ± 3.0 mm Hg, you will
be able to determine the accuracy of the unit being tested to within ± 6.0 mm Hg.
If using a device (e.g., digital pressure standard) rated at ± 1.0 mm Hg, you will be able
to determine the accuracy of the unit being tested to within ± 4.0 mm Hg.
1
Welch Allyn recommends using the most sensitive pressure standard possible when
performing calibration checks. A Setra Pressure Meter 2270-01, which is calibrated for
± 0.1 mm Hg, works well for this application.
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6. Specifications
This section provides the unit specifications for the ABPM 6100 ambulatory blood pressure
monitor.
Power Requirements:
 Two “AA” alkaline batteries or high capacity rechargeable batteries (NimH).
Dimensions:
 124 x 70 x 33 mm (approximate).
Weight:
 270g (including batteries, approximate).
Environmental Operating Condition:
 Atmospheric Pressure Range of 700 HPA to 1060 HPA
Protection against electric shock:
 Internally powered, Type BF
Operating Ambients:
 Temperature: 10°C (50°F) to 50°C (122°F).
 Humidity: 20% to 95% RH non-condensing.
Storage Ambients:
 Temperature: -20°C (-68°F) to 70°C (158°F).
 Humidity: 15% to 95% RH non-condensing.
 Altitude: -170 to 1,700 meters
Gauging Ranges:
 Systolic Blood Pressure: 60 to 250 mmHg
 Diastolic Blood Pressure: 25 to 200 mmHg
 Maximum Inflation: 270 mmHg
 Heart Rate: 40 to 200 bpm
Memory:
 Up to 250 readings using Alkaline batteries
 Up to 110 reading using rechargeable NimH
Method of Measurement:
 Oscillometric with step deflation.
Accuracy:
 ± 3 mmHg
International Standards:
 EN 60601-1-1:2001 ; Medical electrical equipment – Part 1-1: General requirements for
safety. Collateral standard: Safety requirements for medical electrical systems
Specific requirements for the protection against hazards of ignition of flammable
anesthetic mixtures and to control the risk of fire (Fire prevention)
 EN 60601-2-30:2000 ; Medical electrical equipment – Part 2-30: Particular requirements
for the safety, including essential performance, of automatic cycling non-invasive blood
pressuring monitoring equipment
 EN 60601-1-2:2001 ; Medical Electrical Equipment – Part 1-2: General requirements for
safety. Collateral Standard: Electromagnetic compatibility – requirements and tests
 EN 1060-1:1996 ; Specification for Non-invasive sphygmomanometers – Part 1.
General requirements
 EN 1060-3:1997 ; Non-invasive sphygmomanometers – Part 3: Supplementary
requirements for electro-mechanical blood pressure measuring systems
 AAMI SP 10 ES1 Category C: 1992 (battery powered) Electronic or automated
sphygmomanometers
Calibration:
 Minimally, once per year
Safety System:
 Maximum Inflation pressure limited to 300 mmHg.
 Auto safety release valve for power failure.
 Maximum BP measurement time limited to less than 180 seconds.
Data Connector:
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ABPM 6100 Hardware Manual
 Stereo mini-plug headphone type connector.
Operator Control:
 1-button control and LCD.
Automatic Measurement Intervals:
 Programmable up to four separate time periods at 5 to 120 minute intervals.
7. Classification
Protection against electric shock:
 Internally powered, Type BF
Protection against the ingress of liquids:
 IPXØ, per IEC 60529
8. Discarding the Equipment
Discard the old battery appropriately.
• In the USA, call 1800-SAV-LEAD for instructions on recycling it.
• International users, contact your local authorities concerning
recycling.
• Discard the ABPM 6100 and accessories according to local laws.
Do not dispose of this product as unsorted municipal waste. Prepare
this product for reuse or separate collection as specified by Directive
2002/ 96/EC of the European Parliament and the Council of the
European Union on Waste Electronic and Electrical Equipment
(WEEE). If this product is contaminated, this directive does not
apply. For more specific disposal information, see
www.welchallyn.com/weee, or contact Welch Allyn
Customer Service.
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9. Troubleshooting and Error Codes
9.1
Error Codes
The ABPM 6100 monitor displays error codes whenever an error situation is encountered.
Error codes will display on the unit’s LCD. Error codes that apply to a specific reading will
also display in the CardioPerfect Workstation Software when the data is read from the unit.
The following table explains error codes generated by the ABPM 6100 monitor along with
possible solutions for each error code.
Error Code
2
Description
Weak or no oscillometric
signal
Artifact/Erratic Oscillometric
Signal
3
Exceeded retry count (4
inflate attempts)
4
Exceeded measurement
time limit
85
Reading aborted (blocked
valves or pneumatics)
1
86
87
88
89
90
91
97
98
99
Reading aborted (manual
abort)
Reading aborted (inflate
time-out or air leak)
Reading aborted (safety
time-out)
Reading aborted (cuff
overpressure)
Service Required (power
supply out-of-range or other
hardware problem)
Service Required (safety
override fitted or autozero
out-of-range)
Service Required
Transducer out-of-range
Service Required (A/D outof-range)
Service Required (EEPROM
calibration data CRC failure)
Solution
Check cuff position and cuff
tightness
Instruct patient to remain still
during reading. Try reading
again.
Instruct patient to remain still
during reading. Try reading
again.
Check air hose connections
and make certain cuff is tight
enough.
Check air hose connections
and make certain air tubing
is not crimped.
Push Start/Stop button to
restart reading
Check air hose and cuff
Push Start/Stop button to
restart reading. If problem
persists, return for
servicing.*
Check air hose for blockage
or kinking
Replace batteries. If problem
persists, return for
servicing.*
Push Start/Stop button to
retry reading. If problem
persists, return for
servicing.*
Return for servicing*
Return for servicing*
Unit needs to be
recalibrated. Return for
servicing.*
The codes mentioned above, are the codes as shown on the device display. Please refer to
the CPWS ABP Software manual for the codes as used by the software.
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ABPM 6100 Hardware Manual
*
9.2
Always return ABPM 6100 monitor to an authorized service center for repairs.
Unauthorized service will void all warranties.
Troubleshooting
The following table contains a list of troublesome scenarios accompanied by suggestions
for problem solving.
Trouble
Cycle starts but cuff will not fully inflate
Blood Pressure readings are not displayed
during Regular Runs.
Patient activation button does not initiate
readings while in the Regular Run mode.
Time Regular Runs do not initiate
Blood Pressure readings are failing with
error codes being displayed
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Response to Trouble
Ensure a connection with the ABPM 6100
monitor is secure and check bladder for
leak; replace if needed. Replace batteries
and try again.
Verify that the display setting is ON in the
Basic Parameters menu.
Verify that Start Button is ON in the Basic
Parameters menu.
Make sure that the time period is not set for
MAN (manual) operation.
Refer to the Error Codes section
CardioPerfect Workstation Software manual.
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ABPM 6100 Hardware Manual
10. Guidance and Manufacturer’s Declarations
CAUTION
The ABPM6100 needs special precautions regarding EMC and needs to be installed and
put into service according to the following EMC information provided.
Portable and mobile RF communications equipment can affect the ABPM6100.
Electromagnetic Emissions
The ABPM6100 is intended for use in the electromagnetic environment specified below. The customer or the user
of the ABPM6100 should assure that it is used in such an environment.
Emissions test
RF emissions
Compliance
Group 1
CISPR 11
RF emissions
Electromagnetic environment – guidance
The ABPM6100 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Class B
CISPR 11
Harmonic emissions
n.a.
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
The ABPM6100 is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
n.a.
IEC 61000-3-3
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ABPM 6100 Hardware Manual
Electromagnetic Immunity
The ABPM6100 is intended for use in the electromagnetic environment specified below. The customer or the user
of the ABPM6100 should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment
–
guidance
6 kV contact
6 kV contact
8 kV air
8 kV air
Electrical fast
transient/burst
±2 kV for power supply
lines
n.a.
IEC 61000-4-4
Mains power quality should be
that of a typical commercial or
hospital environment.
±1 kV for input/output
lines
Surge
1 kV differential mode
n.a.
IEC 61000-4-5
2 kV common mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
n.a.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the ABPM6100 requires
continued operation during
power mains interruptions, it is
recommended that the
ABPM6100 be powered from an
uninterruptible power supply or
a battery.
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
Electrostatic discharge
(ESD)
IEC 61000-4-2
IEC 61000-4-11
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30 %.
<5 % UT
(>95 % dip in UT)
for 5 sec
Power frequency (50/60
Hz) magnetic field
3 A/m
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
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ABPM 6100 Hardware Manual
Electromagnetic Immunity
The ABPM6100 is intended for use in the electromagnetic environment specified below. The customer or the user
of the ABPM6100 should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Electromagnetic environment –
guidance
Compliance level

Portable and mobile RF communications
equipment should be used no closer to any
part of the ABPM6100, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2,5 GHz
n.a.
d  1.2  P
3 V/m
d  1.2  P
80 to 800 MHz
d  2.3  P
800 MHz to 2,5 GHz
where P is the maximum output power
rating of the transmitter in watts (W) and d
is the recommended separation distance in
metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey a, should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the ABPM6100 is used
exceeds the applicable RF compliance level above, the ABPM6100 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the ABPM6100.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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ABPM 6100 Hardware Manual
Recommended separation distances between portable and mobile RF
communications equipment and the ABPM6100
The ABPM6100 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the ABPM6100 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the ABPM6100 as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 KHz to 80 MHz
d  1.2  P 
80 MHz to 800 MHz
800 MHz to 2,5 GHz
d  1.2  P
d  2.3  P
0,01
0.12
0.12
0.23
0,1
0.37
0.37
0.74
1
1.2
1.2
2.3
10
3.7
3.7
7.4
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
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