Welch Allyn ABPM 6100 User Manual

ABPM 6100 Hardware Manual

Welch Allyn

Staalweg 50
2612 KK Delft
The Netherlands

0297

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Welch Allyn

4341 State Street Road
Skaneateles Falls, NY
13153-0220 USA
www.welchallyn.com

ABPM 6100 Hardware Manual

Copyright

© Copyright 2008, Welch Allyn. All rights are reserved. No one is permitted to translate,
reproduce or duplicate this manual or any part thereof, in any form, without prior written
permission from 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 up­to-date information to users and operators alike.

Welch Allyn®, CardioPerfect® Workstation and SpiroPerfect® are registered tradema rks of
Welch Allyn.

Software in this product is Copyright 2008, 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

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 1-800-535-6663 Canada 1-800-561-8797
Latin America ([phone] South Africa ([phone]
European Call
Center
United Kingdom ([phone] Singapore ([phone]
France ([phone] Japan ([phone]
Germany ([phone] China ([phone]

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 spa re p arts orders, a purchase order (or credit card)

number

• For parts order, the required sp are 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

Packing Instructions

If you have to return goods for service, follow these recommended packing instructions:

• Remove all hoses, cables, sensors, po wer 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 Autho rization (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.

([phone] Australia ([phone]

Welch Allyn does not accept returned products without an RMA.

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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 labeled 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 labeled instructions, 3) alteration or repair by anyone not
authorized by Welch Allyn, and 4) accidents.

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.........................................................................................................8

2.1 Introduction..........................................................................................................................8

2.2 Operation.............................................................................................................................9

3. INTERFACE........................................................................................................................11

3.1 Preliminary Directive..........................................................................................................11

3.2 Prior to Hook-up ................................................................................................................11

3.3 Sizing.................................................................................................................................11

3.4 Traditional Cuff Placement................................................................................................12

3.5 Sleeve Cuff Placement......................................................................................................12

3.6 Office Readings.................................................................................................................14

3.7 Regular Runs.....................................................................................................................14

3.8 Data...................................................................................................................................15

4. KEYSPAN USB TO SERIAL ADAPTER INSTALL............................................................17

5. MAINTENANCE AND CLEANING.....................................................................................20

6. CALIBRATION CHECK......................................................................................................21

7. SPECIFICATIONS...............................................................................................................23

8. TROUBLESHOOTING AND ERROR CODES...................................................................25

8.1 Error Codes.......................................................................................................................25

8.2 Troubleshooting.................................................................................................................26

9. GUIDANCE AND MANUFACTURER’S DECLARATIONS................................................27

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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 ABP Workstation
Software is available in the ABP 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.

Safety and Effectiveness Warnings

Make sure that you are familiar with all Safety and Effectiveness considerations before
using the ABPM 6100 monitor.

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.

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ABPM 6100 Hardware Manual

IMPORTANT WARNINGS

The following warnings apply to the ABPM 6100 Ambulatory Blood Pressure Monitors:

DO NOT use the ABPM 6100 monitor in the presence of flammable

Warning

Caution

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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.

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 is defibrillator protected. The ABPM 6100 has no

specific precautions during defibrillation, and defibrillation has no
effect on the ABPM 6100 monitor.

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 ABP 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

- Keyspan serial adapter including CD

- Adult Size Cuff

- 4 AA Batteries

- ABPM 6100 hardware & ABP Workstation Software Manual CD

- Monitor Pouch

Substitution of a component different from that supplied might

Caution

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.

result in measurement error!

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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 ABP
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 rem oved
before the unit was turned off)

- One long audible beep.

- Displays flashing time for 20 seconds (after 20 seconds the u nits turns itself off and

goes into Sleep Mode to conserve battery life)

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