Welch Allyn ABPM 7100 Directions For Use 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

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.

• 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 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:

• Directive 93/42/EEC (MDD)

• Directive 1999/5/EC (R&TTE)

• Directive 2011/65/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.

• Only use accessories approved and distributed by the manufacturer and Welch Allyn.

• Check the accessories regarding the manufacturer’s information 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

• The ABPM 7100 is an automated, microprocessor controlled 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.

• It is used with a standard upper-arm cuff for blood pressure measurement.

• 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 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

• The ABPM 7100 must not be used on neonates and children under the age of 3 years!

• Due to the strangulation risk posed by tubing and cuff, 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!

• The ABPM 7100 is not intended for alarm triggering monitoring 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:

• 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.

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:

• 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.

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

•

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

e

rror

s

•

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.

Product description - 10

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

EN

11 - Preparing the ABPM 7100

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).

• When used on children, the device must only be applied with special care and under permanent

supervision.

• Instruct the patient to turn off the device, 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.)

• Measurement can be interrupted at any stage by pushing 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.

• Do not use the cuff on patients with a known hypersensitivity to epoxy resin.

Caution

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 and the

cuff does not result in impaired blood circulation.

• If the patient has limited cognitive abilities, the device may only be used under supervision.

• When used on children, the device must only be applied with special care and under permanent

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 turn off the device, 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.

• The doctor must ensure that, due to the patient’s medical condition, the use of the device and the

cuff does not result in impaired blood circulation.

• If the patient is has limited cognitive abilities, the device may only be used under supervision.

• When used on children, the device must only be applied with special care and under permanent

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 under 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 turn off the device, 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.

•

Wash to remove residues.

•

Wash the cuff sleeve with a mild detergent in the washing machine at max. 30°C without spinning.

Inserting the batteries

Attention

Damage to device

•

Do not wear the ABPM 7100 while showering! If you suspect that liquid has entered the device while

cleaning or using it, the device shall no longer be used on the patient.

•

If the device was exposed to moisture, switch off the device and remove the batteries.

•

Inform your service immediately and send the device in for inspection.

•

The device may not be operated around MRI scanners or in the immediate vicinity of other medical

electrical equipment.

•

During a defibrillator discharge, the device shall not be in contact with the patient. Such a discharge

may damage the ABPM 7100 and cause it to display incorrect values.

•

The ABPM 7100 is not suitable for simultaneous use with HF surgical equipment.

•

Measurement can be interrupted at any stage by pushing a random button. This deflates the cuff and

the device can be removed.

Attention

Device function

•

Although zinc-carbon batteries may indicate sufficient voltage during a battery test, their output is

frequently insufficient to perform 24-hour measurements.

•

To conduct measurements over 48 hours, you will need 2 additional batteries as replacement after

24 hours.

Attention

Damage to device

•

Do not open the casing. Once the device is opened, 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

•

Always use fully charged batteries for a new measurement

•

Only use undamaged batteries

•

Please remove the batteries if the device has not been used for a longer period

•

When inserting the batteries, please ensure correct polarity

13 - Preparing the ABPM 7100

Activating the device

Attention

Damage to device

• Do not wear the ABPM 7100 while showering. If you suspect that liquid has entered the device while

cleaning or using it, the device shall no longer be used on the patient.

• In the device was exposed to moisture, switch off the device and remove the batteries.

• Inform your service immediately and send the device in for inspection.

• The device may not be operated around MRI scanners or in the immediate vicinity of other medical

electrical equipment.

• During a defibrillator discharge, the device shall not be in contact with the patient. Such a discharge

may damage the ABPM 7100 and cause it to display incorrect values.

• The ABPM 7100 is not suitable for simultaneous use with HF surgical equipment.

• Measurement can be interrupted at any stage by pushing a random button. This deflates the cuff and

the device can be removed.

Attention

Hygiene

• Ensure hygiene in accordance with the maintenance schedule.

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

• Logs 1, 2, 10 and 11 are set by default but can be changed via the patient management

software.

• Log 5 is suitable for nighttime activities (night shift).

• Log 9 is designated as “Schellong-Test”.

• Log 10 automatically sends the measurement values to your doctor’s PC via Bluetooth®.

Bluetooth® communication is not supported with the CPWS software.

• Log 11 is only available to upgraded ABPM 7100 systems 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

00:00 07:59 2 NO

2 08:00 22:59 4 YES YES

23:00 07:59 1 NO

3 07:00 21:59 4 YES NO

22:00 06:59 2 NO

4 08:00 23:59 4 YES NO

00:00 07:59 2 NO

5 18:00 09:59 4 YES YES

10:00 17:59 2 NO

6 07:00 23:59 4 YES YES

00:00 06:59 2 NO

7 06:00 22:59 4 YES NO

23:00 05:59 2 NO

8 07:00 08:59 6 YES YES

09:00 23:59 4 YES

00:00 06:59 2 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

00:00 07:59 2 NO

EN

15 - Preparing the ABPM 7100

Selecting a suitable cuff

Caution

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 and the

cuff does not result in impaired blood circulation.

• If the patient is has limited cognitive abilities, the device may only be used under supervision.

• When used on children, the device must only be applied with special care and under permanent

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 under 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 turn off the device, 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.

• Wash to remove residues.

• Wash the cuff sleeve with a mild detergent in the washing 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.

• If the patient is 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).

• When used on children, the device must only be applied with special care and under permanent

supervision.

• Instruct the patient to turn off the device, 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.)

• Measurement can be interrupted at any stage by pushing any of the buttons. This automatically

deflates the cuff and the device can be removed.

Preparing the ABPM 7100 - 16

W a rni n g

Poor circulation caused by continuous cuff pressure.

• Do not kink the connecting tubing.

• If the patient has limited cognitive abilities, the device may only be used under supervision.

• Ensure the correct placement of the shoulder strap and cuff tubing.

• Always place the cuff tubing under the outer clothing (even at night).

• When used on children, the device must only be applied with special care and under permanent

supervision.

• Instruct the patient to turn off the device, 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 rni n 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.

• Examine the patient for wounds, bandages, etc.

• Question the patient regarding previous treatments.

• Observe the patient closely.

• Instruct the patient to turn off the device, 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.

• Wash to remove residues.

• Wash the cuff sleeve with a mild detergent in the washing machine at max. 30°C without spinning.

Caution

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 and the

cuff does not result in impaired blood circulation.

• If the patient has limited cognitive abilities, the device may only be used under supervision.

• When used on children, the device must only be applied with special care and under permanent

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 under 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 turn off the device, 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.)

17 - Preparing the ABPM 7100

Caution

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 and the

cuff does not result in impaired blood circulation.

• If the patient has limited cognitive abilities, the device may only be used under supervision.

• When used on children, the device must only be applied with special care and under permanent

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 turn off the device, 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.)

Applying the ABP Monitor and cuff:

1. Position the carrying pouch on the right side of the patient. By varying the length of the pouch strap, it

can be worn around the hips or around the shoulders.

2. Alternatively a normal belt matching the clothes can be used.

3. Fit the cuff onto the patient.

The correct cuff seating is very important for correct blood pressure measurement.

4. Align the cuff so that no part of the cuff tubing is kinked. In this regard, the tube connection on the cuff

must face upwards.

5. Align the cuff so that the lower edge of the cuff is approximately 2 cm above the inside of the patient’s

elbow.

6. Tighten the cuff around the upper arm until one finger can be introduced under the cuff.

7. It is imperative that the artery symbol is positioned on the brachial artery. If you have aligned the cuff

correctly, the metal bar will lie on the outside of the upper arm (on the elbow side), whereby the cuff

sleeve must cover the skin under the metal bar.

8. Guide the tubing through the shirt’s row of buttons and out of the clothing, behind the nape of the neck

to the ABPM 7100 on the right side of the body.

9. The cuff can be worn on the naked upper arm or over a thin shirt sleeve.

10. The placement of the pressure tube must guarantee the upper arm’s free motion.

Connecting the cuff tubing to the ABPM 7100

1. Push the tube firmly onto the connection, with the cuff tubing engaging with an audible “CLICK” (to

detach, simply pull back the knurled ring).

2. Before measurement, check to ensure that tubing, ABPM 7100 and cuff are positioned correctly. The

ABPM 7100 is ready for measurement only once this is ensured.

Measurement process - 18

Positioning the patient for measurement

The patient should take the following position during blood pressure measurement:

• Comfortably seated

• Legs uncrossed

• Feet flat on the ground

• With support to the back and the arms

• With the cuff center at one level with the right atrium

Note

• During measurement, the patient should be as relaxed as possible and may not speak

unless he wants to report any discomfort!

• Allow for 5 minutes of relaxation before recording the first measurement value.

• Blood pressure measurements can be influenced by the patient’s position (standing,

sitting, lying), by exertion or the patient’s physiological state. Exclude these influencing

factors to the greatest possible degree!

Measurement process

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).

• When used on children, the device must only be applied with special care and under permanent

supervision.

• Instruct the patient to turn off the device, 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.)

• Measurement can be interrupted at any stage by pushing any of the buttons. This automatically

deflates the cuff and the device can be removed.

Warning

Poor circulation caused by continuous cuff pressure.

• Do not kink the connecting tubing.

• If the patient has limited cognitive abilities, the device may only be used under supervision.

• Ensure the correct placement of the shoulder strap and cuff tubing.

• Always place the cuff tubing under the outer clothing (even at night).

• When used on children, the device must only be applied with special care and under permanent

supervision.

• Instruct the patient to turn off the device, 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 rni n g

Poor circulation due to overly frequent measurements.

• Check the date of the last measurement.

• Inform the patient about this warning.

• If the patient has limited cognitive abilities, the device may only be used under supervision.

• Observe the patient closely.

• Instruct the patient to turn off the device, 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.)

EN

19 - Measurement process

W a rni n g

If the patient is wearing an additional ME device on the same limb for monitoring purposes,

the

placement and inflation of the cuff may trigger the temporary loss of the existing ME device’s

function.

The operation and use of the automated non-invasive blood pressure monitoring device may lead

to longer impaired blood circulation in the patient or respective limb.

• Examine the patient.

• Question the patient regarding previous treatments.

• Observe the patient closely.

• Instruct the patient to turn off the device, 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.

• The doctor must ensure that, due to the patient’s medical condition, the use of the device and the

cuff does not result in impaired blood circulation.

• If the patient has limited cognitive abilities, the device may only be used under supervision.

• When used on children, the device must only be applied with special care and under permanent

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 under 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 turn off the device, 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.

• Wash to remove residues.

• Wash the cuff sleeve with a mild detergent in the washing machine at max. 30°C without spinning.

Attention

Damage to device

• Do not wear the ABPM 7100 while showering. If you suspect that liquid has entered the device while

cleaning or using it, the device shall no longer be used on the patient.

• In the device was exposed to moisture, switch off the device and remove the batteries.

• Inform your service immediately and send the device in for inspection.

• The device may not be operated around MRI scanners or in the immediate vicinity of other medical

electrical equipment.

• During a defibrillator discharge, the device shall not be in contact with the patient. Such a discharge

may damage the ABPM 7100 and cause it to display incorrect values.

• The ABPM 7100 is not suitable for simultaneous use with HF surgical equipment.

• Measurement can be interrupted at any stage by pushing a random button. This deflates the cuff and

the device can be removed.

Attention

Hygiene

•

Ensure hygiene in accordance with the maintenance schedule.

Measurement process - 20

Attention

Measurement errors

• The use of components not included in the scope of delivery may lead to measurement errors. Only

use the accessories offered by Welch Allyn.

• Although the ABPM 7100 fulfills all EMC standard requirements, it should not be exposed to any

strong electromagnetic fields, as this may lead to malfunctions outside the limit values.

• Medical electrical equipment is subject to special EMC precautions. Please observe the directives

attached.

• The cuff tubing between the ABPM 7100 and the cuff may not be knotted, compressed or pulled

apart.

• The cuff connection must always engage with an audible “CLICK”. A loose connection between the

tubing and the device leads to measurement errors.

Initial measurement

24-hour measurement

1. Ensure sufficient battery voltage. At least 2.6 volts for NiMH batteries and at least 3.10 volts for

alkaline batteries!

2. The doctor must go through these instructions together with the patient before a 24-hour

measurement.

3. The doctor must explain the possible hazards in detail on the basis of the warnings above!

4. Ensure that the patient has understood all functions and observable points!

Safety:

For your own safety during the following steps, please observe the safety instructions at the

start of this chapter, as well as the functional overview.

Performing a measurement

1. To trigger a measurement, press the START button.

• The number of stored measurements will be shown on the LCD display.

• An audio beep will announce the upcoming measurement.

• Manual measurement will start.

2. The patient should stay calm during the measurement process, until the measurement is completed.

Allow your arm to hang loose, or place your lower arm loosely on the table or on a support whilst

sitting. Avoid any movement!

3. Doctor: Please check the values of the first measurement for plausibility, so that subsequent automatic

measurements can be processed correctly and correct cuff position is ensured.

4. In the event of an error measurement, please follow the instructions in sections Measurement

preparations and Troubleshooting.

Note

• Severe malfunctions are indicated by a continuous beep.

• In the event of a continuous beep, switch off the device, remove the cuff and inform your

doctor.

• Hand the data sheet “Patient information – operation of the ABPM 7100” to each patient.

The data sheet is attached as a copy template.

• Portable and mobile HF communication equipment may influence medical electrical devices.

• Extreme temperatures, humidity or air pressure can influence measurement accuracy.

Please observe the operating conditions.

• There are currently no clinical studies against reference methods available at respect to the

application of pulse wave analysis on children.

• The pulse wave analysis provides additional indicators for possible risks, but is not

permissible as a sufficient indicator for individual illness or as a treatment recommendation.

Note

An initial measurement is required for starting the measurement log. The initial measurement

must be checked by a physician for plausibility!

21 - Care and Maintenance

Cancelling a measurement

A measurement will be cancelled by pressing any buttons during the measurement process. The LCD

display will then show -StoP- and the ABPM 7100 will beep 5 times. This cancellation will be stored in the

measurement value table under Cancel.

Unsuccessful measurement

1. If the display shows errors, reexamine the correct procedure during set-up and positioning of the

device.

2. Dismiss the patient only after a successful manual measurement!

Inform the patient sufficiently in order to explain the situation!

3. Repeat the measurement.

4. If the display still shows errors, repeat the initial operation process.

5. For further troubleshooting measures and faults removal, please refer to the Troubleshooting section.

Note

• Severe malfunctions are indicated by a continuous beep.

• In the event of a continuous beep, switch off the device, remove the cuff and inform

your doctor.

Pos: 13 /_Steuerung/==========SEITENUMBRUCH========== @ 0\ mod_ 13 999 679 5 7149 _6 .doc x @ 48 04 @ @ 1

Care and Maintenance

To ensure the optimal functionality of the ABPM 7100 regular care and maintenance of the unit is required.

Attention

Damage to device

• Do not open the casing. Once the device is opened, all warranties will lapse.

Cleaning

Cleaning the ABP Monitor and carrying pouch

1. Read the safety instructions carefully and observe them closely before cleaning.

2. Only use a cotton cloth moistened with lukewarm water and mild detergents to clean the ABPM 7100

and the pouch.

Attention

Damage to the ABP Monitor and carrying pouch caused by the use of solvents

• Do not use strong or solvent-based additives.

• Ensure that no liquid enters the device.

• If liquid does penetrate the device, switch if off immediately and return it to your Welch Allyn

specialist for inspection.

Cleaning the cuff sleeve, bladder and tubing

1. Read the safety instructions carefully and observe them closely before cleaning.

2. Before washing, carefully remove the bladder and tubing from the cuff sleeve.

3. When cleaning the cuff sleeve, bladder and tubing, use only mild detergents in lukewarm water without

fabric softener.

Attention

Damage to the cuff sleeve during washing

• Always close the Velcro strip before washing!

• It is possible to wash the cuff sleeve in the washing machine at max. 30°C. Do not spin.

• Do not use fabric softeners or other washing aids (e.g. hygiene rinses, textile deodorants). These

agents can leave behind residues and damage the material.

• The cuff sleeve is not suitable for drying in a dryer.

Care and Maintenance - 22

Disinfection

Caution

Intolerances caused by the use of disinfectants: Some patients display intolerance (e.g. allergies)

to disinfectants or their components.

•

Never use disinfectants which leave residues on the product or which are not suitable for contact

with the skin.

•

Carefully wash the cuff to remove residues.

Attention

Damage to the cuff sleeve, bladder and tubing caused by disinfectants

•

Do not submerge the cuff sleeve in disinfectants.

•

Avoid disinfecting the cuff bladder and connected rubber tubing.

•

The bladder and tubing can be damaged by disinfectants. Wipe down the bladder with lukewarm

water and add a mild detergent, if necessary.

•

Ensure that no liquid enters the tube opening.

The user (doctor) decides whether and when the ABP Monitor and the cuff sleeve should be disinfected for

hygienic reasons (e.g. after every use).

The following agents are recommended for disinfecting the ABP Monitor and the cuff sleeve:

•

Terralin Liquid (Manufacturer: Schülke & Mayr)

•

Isopropyl alcohol (70%)

For full effectiveness, moisten the ABPM 7100 and cuff sleeve with the disinfectant for at least 5 minutes.

The use of disinfectants not recommended by Welch Allyn shall render the user responsible for proof of safe

application.

Note

It is imperative that you observe the manufacturer’s information regarding the use of these

products. Allow the agents to dry off completely.

Maintenance plan

Attention

Damage to device

•

Do not open the casing. Once the device is opened, all warranties will lapse.

Weekly Maintenance

Analysis review:

1. Review the print-out of your measurement analysis for:

•

Correctly entered times and intervals in accordance with the log.

•

Times of day/night transitions.

•

Correct standard values (nocturnal decrease).

2. Check the device, cuff and the cuff tubing for superficial soiling and clean it as specified in the

Cleaning

section.

3. Check the cuff and the cuff tubing for superficial damage. In the event of damages return it to your

Welch Allyn specialist for inspection.

Checking battery voltage:

Always use fully charged or new batteries.

The battery voltage appears on the display of the ABPM 7100 for approximately 3 seconds after the device is

switched on. The battery voltage must be at least 2.6 volt to ensure a 24-hour measurement.

EN

23 - Troubleshooting

Maintenance every 2 years

As proof of continuous compliance to “Basic Requirements” pursuant to Directive 93/42/EEC, the ABPM

7100 must be subjected to metrological checks every two years. In certain countries, this requirement may

be regulated by national laws or regulations.

Welch Allyn offers to provide metrological checks and the servicing comprising of the following:

• Metrological monitoring

• Software updates (if required)

• Functional check: Electronics, pump and pneumatic circuit

Troubleshooting

Attention

Damage to device

• Do not open the casing. Once the device is opened, all warranties will lapse.

Basic error sources

The following may cause error measurements or unintended events:

• The patient’s arm movement during measurement

• Incorrect cuff size

• Cuff displacement while wearing it

• Omitted successful initial measurement by the doctor

• Wrong log set by the user

• Empty, incorrectly charged or outdated batteries

• Kinked or knotted cuff tubing

• Severe arrhythmia

Transmission error

The ABPM 7100 reviews the transmitted data to prevent errors. If an error occurs, “E004” will be shown on

the display.

Checklist

Please review the following checklist for any errors occurring during the operation of the ABPM 7100. Many

errors have simple causes:

• Check to see that all cables are connected correctly.

• Check to see whether the ABPM 7100 and the computer are switched on.

• Check to see whether the batteries have sufficiently voltage.

Note Some errors are combined with a continuous alarm for safety reasons. The continuous alarm

can be cancelled by pressing any button. If there is residual pressure inside the cuff, open the

cuff immediately.

Troubleshooting - 24

Error codes

Error description of the ABPM 7100

Error symptom Possible cause Remedy

Time and date are not

updated following a

longer period without

power supply from power

packs or batteries.

The internal buffer battery is

depleted.

Date and time can be reset after every

power pack or battery replacement.

Send the device to your Welch Allyn

specialist.

Measurement data can

no longer be called

up/displayed.

An error occurred during patient

data storage.

Delete the respective patient (menu bar) and

recreate it.

The connection between

the ABPM 7100 and the

PC is faulty.

The incorrect COM interface is

set.

Set the correct interface in the service

programs.

Cable plug or socket is defective.

Inspect the plug and the socket on the

ABPM 7100. Ensure that the pins are

straight to guarantee contact.

The ABPM 7100 is not in

transmitting mode (the displays

shows the time).

Switch the ABPM 7100 off and then on

again without removing the connecting

cable.

No patient number.

The ABP Monitor is not

initialized, i.e. the patient number

was not transferred during the

preparation for a 24-hour

measurement.

The patient number can also be transmitted

after the measurement. This does not

influence the measurement data.

No measurements were

conducted during the

nocturnal phase.

The battery packs or batteries

were prematurely depleted.

The power packs or batteries may be

defective (please contact your Welch Allyn

specialist).

The patient has switched off the

ABPM 7100.

Draw the patient’s attention to the urgency of

a complete 24-hour measurement.

The display does not

show “co” or “bt”.

You are not in transmitting mode.

Communication via cable: Switch the ABPM

7100 off and then on again without pulling

the plug.

Communication via BT: Press and hold the

START button and then press the

DAY/NIGHT button. Select “bt” using the

START button.

No automatic

measurements will be

performed.

No manual measurements

performed after application.

Valid manual measurement must always be

performed after the device has been

positioned.

Incorrect log set. Set log 1 or 2.

The measurement

interval does not meet

your expectations.

Incorrect log set.

The programmed log does not correspond

with the set log in the ABPM 7100. Check

the log manually on the device.

No manual measurements

performed after application.

Conduct manual measurement to activate

the set log

25 - Troubleshooting

Error symptom Possible cause Remedy

Err 1

The patient displays severe

arrhythmia.

ABP Monitor not applicable.

The arm was moved during

measurement.

Keep the arm still during measurement.

Insufficient valid pulse rate detected.

Place the cuff on your arm again.

Err 2

The arm was moved during

measurement.

Keep the arm still during measurement.

Cuff does not fit the arm snugly.

Check the seating of the cuff and that of the

device.

Err 3

Blood pressure beyond the

measurement range.

Permanent notification renders the ABP

Monitor unsuitable for the patient.

Strong arm movements. Keep the arm still during measurement.

Problems with the pneumatics.

If the error persists permanently, send the

device to your Welch Allyn specialist.

Err 4

Data transmission cable incorrectly

inserted in ABP Monitor.

Insert the cable into the ABP Monitor

correctly.

Pins in the plug of the data

transmission cable are mechanically

damaged.

Check the plug to see whether the pins on

the inside are damaged. If they are, contact

your Welch Allyn specialist.

Measurement value was not

correctly transmitted.

Restart the transmission.

Err 5

bAtt

Power pack or battery voltage too

low.

Replace the power packs or batteries.

Power packs or batteries are

defective.

The power pack or battery voltage is correct

but “bAtt” is displayed during cuff inflation.

Replace the power packs.

Battery contacts are corroded.

Clean the battery contacts with a cotton

cloth and a little alcohol.

Err 6 +

Possible continuous

alarm until a button is

pressed.

Build-up 25 fair.

Check the cuff for a build-up of air or a kink

in the tubing. If the cuff tubing is kinked,

straighten the tubing. Otherwise send the

device in for inspection immediately.

Blood pressure cuff incorrectly

connected.

Connect the cuff to the device.

Leaky points in the cuff or the cuff

tubing.

If necessary, replace the cuff.

Err 7

The memory of the blood pressure

measurement device is full. (a

maximum of 300 measurements and

events can be stored)

Delete the data in the ABP Monitor but

ensure that the data was stored on your PC

first.

Err 8

Measurement cancelled with a

pressed button.

Err 9 +

Possible continuous

alarm until a button is

pressed.

Residual pressure inside the cuff Wait for the cuff to deflate completely.

Zero point comparison was

unsuccessful.

Send the device to your specialist for

inspection immediately or directly to your

Welch Allyn specialist.

Troubleshooting - 26

Error symptom Possible cause Remedy

Err 10 +

Continuous alarm

until a button is

pressed.

Severe error caused by accumulated

pressure outside the measurement

process.

Send the device to your specialist for

inspection and repair immediately or

directly to your Welch Allyn specialist.

These error messages all show a

severe error in the program code.

The analysis unit

does not react to data

transmission but the

display shows “co”.

Data transmission cable not correctly

inserted in the PC. (also refer to Err 4)

Check whether the 9-pin plug of the data

transmission cable is securely seated in

the device’s interface socket. (also refer to

Err 4)

The ABPM 7100

measures every two

minutes.

Log 9 is set in the ABPM 7100. Set log 1 or 2.

The desired log

cannot be set with the

button combination.

The last patient’s measurement

values are still contained in the

memory.

Delete the data in the ABP Monitor but

ensure that the data was stored first.

The ABP Monitor

cannot be switched

on.

The battery packs or batteries were

incorrectly inserted.

Reinsert either power packs or batteries

and ensure correct polarity.

Power pack or battery voltage too low.

Replace the power packs or batteries.

Defective display.

Send the device to your specialist for

repair or directly to your Welch Allyn

specialist.

An error occurs during

the first

measurement.

The cuff size is not suitable for the

patient’s arm circumference.

Measure the patient’s arm circumference

and compare this with the imprint on the

cuff. You may require a different cuff size.

Communication error ABPM 7100 Bluetooth Interface

Error symptom Possible cause Remedy

Code 1

Bluetooth

®

interface of the ABPM 7100 was not

started correctly.

Possible hardware fault.

Send the device to your Welch Allyn

specialist for inspection.

Code 2

Bluetooth

®

interface of the ABPM 7100 could

not be configured correctly.

(Communication problem between ABPM 7100

and the Bluetooth

®

module.)

Try again. If the error persists, send

the device to your Welch Allyn

specialist for inspection.

Code 3

The status of the Bluetooth

®

interface of the

ABPM 7100 could not be determined.

(Communication problem between ABPM 7100

and the Bluetooth® module.)

Try again. If the error persists, send

the device to your Welch Allyn

specialist for inspection.

Code 4

The Bluetooth

®

interface of the ABPM 7100 has

not yet been paired with the analysis software.

Reconnect the device via Bluetooth

®

.

Code 5

The Bluetooth

®

interface of the ABPM 7100

could not connect to the Bluetooth dongle on

the computer.

Try again. If the error persists, send

the device to your Welch Allyn

specialist for inspection.

Code 6

The measurement value memory of the ABPM

7100 contains unsent blood pressure values.

These will be sent once further

measurements have been performed.

Code 7

The ABPM 7100 is paired with a cell phone or

GSM modem, which is technically incapable of

transmitting measurement values, is outside the

network range or is incorrectly configured.

Try again. If the error persists, contact

your Welch Allyn specialist.

EN

27 - Limited Warranty

Limited Warranty

Welch Allyn warrants the product to be free of defects in material and workmanship and to perform in

accordance with manufacturer's specifications for the period of one year from the date of purchase from Welch

Allyn or its authorized distributors or agents.

The warranty period shall start on the date of purchase. The date of purchase is: 1) the invoiced ship date if

the device was purchased directly from Welch Allyn, 2) the date specified during product registration, 3) the

date of purchase of the product from a Welch Allyn authorized distributor as documented from a receipt from

said distributor.

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.

The product warranty is also subject to the following terms and limitations: Accessories are not covered by the

warranty. Refer to the directions for use provided with individual accessories for warranty information.

Shipping cost to return a device to a Welch Allyn Service center is not included.

A service notification number must be obtained from Welch Allyn prior to returning any products or

accessories to Welch Allyn's designated service centers for repair. To obtain a service notification number,

contact Welch Allyn Technical Support.

THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT

NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILTY 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.

Service Policy

All repairs on products under warranty must be performed by Welch Allyn or by a service provider authorized

by Welch Allyn. Unauthorized repairs will void the warranty. In addition, whether or not covered under

warranty, any product repair should be performed exclusively by Welch Allyn or by a service provider that

has been authorized by Welch Allyn.

If the product fails to function properly - or if you need assistance, service, or spare parts - contact the

nearest Welch Allyn Technical Support Center.

Before contacting Welch Allyn, try to duplicate the problem, and check all accessories to ensure that they are

not causing the problem. When calling, please be prepared to provide:

• Product name, model number, and serial number of your product.

• Complete description of the problem.

• 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 orders, the required spare or replacement part numbers.

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 of your product.

In case a 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. An RMA number

must be obtained prior to any return.

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

• Remove all hoses, cables, sensors, power cords, and other accessories (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.

EMC Guidelines and Manufacturer Declaration - 28

Pos: 20 /Sammel/08 _Anhang @ 0\mod_1400228500241_6.docx @ 4869 @ 123333 @ 1

EMC Guidelines and Manufacturer Declaration

Table 1 – Guidelines and Manufacturer Declaration

Electromagnetic emission for all ME devices and ME systems

Guidelines and Manufacturer Declaration - Electromagnetic emissions

The ABPM 7100 is intended for operation in an electromagnetic environment as specified below. The

customer or user of the ABPM 7100 should ensure it is used in such an environment.

Emission measurement Compliance Electromagnetic Environment Guideline

HF Emissions according to CISPR 11 Group 1

The ABPM 7100 utilizes HF power for its

internal function only. Its HF emission is

therefore very low and it is improbable that

neighbouring electronic device experience any

interference.

HF Emissions according to CISPR 11 Class B

The ABPM 7100 is suitable for use in other

facilities than the living area and those

immediately connected to the public supply

network, which also supplies buildings used for

residential purposes.

Emission of harmonics

according to IEC 61000-3-2

Not applicable

Emission of voltage fluctuations/

flickers according to IEC 61000-3-3

Not applicable

Table 2 – Recommended safety distances between portable and mobile HF communication devices

and the ME device or ME system for ME devices or ME systems, which are not life-supporting

Recommended safety distances between portable and mobile HF tel

ecommunication devices and

the ABPM 7100

The ABPM 7100 is intended for operation in an electromagnetic environment, in which disturbance variables

are controlled. The customer or user of the ABPM 7100 can assist in preventing electromagnetic

interferences by adhering to the minimum distance between portable and mobile HF telecommunication

devices (transmitters) and the ABPM 7100 – depending on the output power of the device, as specified

below.

The transmitter’s nominal

capacity

W

Safety distance, depending on transmission frequency

m

150 kHz to 80 MHz

d = 1.2

80 MHz to 800 MHz

d = 1.2

800 MHz to 2.5 GHz

d = 2.3

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters whose nominal capacity is not covered by the table above, the recommended safety

distance d can be calculated in meters (m) using the formula given in the respective column, whereby P is

the maximum nominal capacity of the transmitters in Watts (W) as per the information given by the

transmitter’s manufacturer.

NOTE 1

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2

These guidelines may not be applicable in all cases. The distribution of electromagnetic

variables is influenced by the absorption and reflection of buildings, objects and people.

29 - EMC Guidelines and Manufacturer Declaration

Table 3 – Guidelines and Manufacturer Declaration

Electromagnetic immunity – for all ME devices and ME systems

Guidelines and Manufacturer Declaration - Electromagnetic immunity

The ABPM 7100 is intended for operation in an electromagnetic environment as specified below. The

customer or user of the ABPM 7100 should ensure it is used in such an environment.

Immunity tests

IEC 60601

-

test

levels

Compliance levels

Electromagnetic Environment

-

Guidelines

Electrostatic

discharge (SD)

according to IEC

61000-4-2

± 6 kV

Contact discharge

± 8 kV

Air discharge

± 6 kV

Contact discharge

± 8 kV

Air discharge

Floors should consist of wood or

cement or ceramic tiles. If the floor

consists of synthetic materials, relative

humidity must be at least 30%.

Rapid transient

electrical

disturbance/bursts

according to IEC

61000-4-4

± 2 kV

for mains cables

± 1 kV

for input and output

lines

Not applicable

± 1 kV

for input and output

lines

The ABPM 7100 does not have an AC

power supply.

Surges

according to IEC

61000-4-5

± 1 kV

Line-to-line voltage

± 2 kV

Line-to-earth voltage

Not applicable

The ABPM 7100 does not have an AC

power supply.

Voltage drops,

short interruptions

and fluctuations in

supply voltage

according to IEC

61000-4-11

< 5% UT

(> 95% drop in UT)

for a 1/2 period

Not applicable The ABPM 7100 does not have an AC

power supply.

40% UT

(60% drop in UT)

for 5 periods

Not applicable

70% UT

(30 % drop in UT)

for 25 periods

Not applicable

< 5% UT

(> 95% drop in UT)

for 5 seconds

Not applicable

Magnetic field in

supply frequency

(50/60 Hz)

according to IEC

61000-4-8

3 A/m 3 A/m Magnet fields in network frequency

should correspond with the typical

values found in business and hospital

environments.

NOTE UT is the AC voltage before the application of the test levels.

EMC Guidelines and Manufacturer Declaration - 30

Table 4 – Guidelines and Manufacturer Declaration

Electromagnetic immunity for ME devices or ME systems that are not life-supporting

Guidelines and Manufacturer Declaration

-

Electromagnetic immunity

The ABPM 7100 is intended for operation in an electromagnetic environment as specified below. The

customer or user of the ABPM 7100 should ensure it is used in such an environment.

Immunity tests

IEC 60601

-

test

levels

Compliance

level

Electromagnetic Environment - Guidelines

Portable and mobile RF communications equipment

should be used no closer to any part of the ABPM

7100, including cables, than the recommended

safety distance calculated from the equation

applicable to the frequency.

Recommended safety distance:

Conducted

disturbance

variables

according to

IEC 61000

-

4

-

6

Effective value

3 V

150 kHz to

80 MHz

3 V

d = 1.2

Radiated

disturbance

variables

according to

IEC 61000-4-3

3 V/m

80 MHz to

2.5 GHz

3 V/m

d = 1.2

for 80 MHz to 800 MHz

d = 2.3

for 800 MHz to 2.5 GHz

with P as the transmitter’s nominal value in watt (W)

according to the transmitter manufacturer’s

information and d as the recommended safety

distance in meters (m).

The field intensity of stationary radio transmitters, as

determined by an electromagnetic on-site

a

survey,

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 be applicable in all cases. The distribution of electromagnetic

variables is influenced by the absorption and reflection of buildings, objects and people.

a

Theoretically, the field intensity of stationary transmitters such as base stations of cellular telephones and

mobile landline devices, amateur radio stations, AM and FM radio and TV stations, cannot be accurately

determined in advance. To assess the electromagnetic environment regarding the stationary transmitter, a

study on the location’s electromagnetic phenomena should be considered. If the measured field strength in

the location in which the ABPM 7100 is used exceeds the applicable RF compliance level above, the

ABPM 7100 should be monitored to verify normal function. If abnormal performance is observed,

additional measures may be necessary, such as re-orienting or relocating the ABPM 7100.

b

Over the frequency range of 150 kHz to 80 MHz, field intensity should be less than 3 V/m.

EN

31 - Compliance

Compliance

General radio compliance

The wireless features of this monitor must be used in strict accordance with the manufacturer’s instructions

as described in the user documentation that comes with the product.

This device complies with Part 15 of the FCC rules and with the rules of the Canadian ICES-003 as

described below.

Federal Communication Commission (FCC) Interference Statement

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

• This device may not cause harmful interference.

• This device must accept any interference received, including interference that may cause undesired

operation.

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to

Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful

interference in a residential installation. This equipment generates, uses, and can radiate radio frequency

energy and, if not installed and used in accordance with the instructions, may cause harmful interference to

radio communications. However, there is no guarantee that interference will not occur in a particular

installation. If this equipment does cause harmful interference to radio or television reception, which can be

determined by turning the equipment off and on, the user is encouraged to try to correct the interference by

one of the following measures:

1. Reorient or relocate the receiving antenna.

2. Increase the separation between the equipment and receiver.

3. Consult the dealer or an experienced radio/TV technician for help.

Any changes or modifications not expressly approved by the party responsible for compliance could void the

user's authority to operate this equipment.

Industry Canada (IC) emissions

This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the

following two conditions: (1) this device may not cause interference, and (2) this device must accept any

interference, including interference that may cause undesired operation of the device.

Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de

licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de

brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le

brouillage est susceptible d'en compromettre le fonctionnement.

This radio transmitter (IC ID: 5123A-BGTWT11IA) has been approved by Industry Canada to operate with

the antenna listed in the specification table.

This Class B digital apparatus complies with Canadian ICES-003.

Cet appareil numérique de la classe B est conform à la norme NMB-003 du Canada.

European Union

Hereby I.E.M. GmbH declares that this ABPM 7100 is in compliance with the essential requirements and

other relevant provisions of Directive 1999/5/EC.

Compliance - 32

Bluetooth

®

Category Feature Implementation

Wireless specification

Bluetooth

v2.1 / v.2.1 + EDR

Transmit Power Class 1, +12 dBm

Range 100 meters line-of-sight

Coexistence

802.11 IEEE 802.11

Antenna

Internal, chip antenna Max. gain 0.5dBi

Environmental Operating Temperature -40C to +85C

Approvals

Bluetooth

FCC / IC / CE / MIC / KC

Registered

Approved

This device is a 2.4 GHz wideband transmission system (transceiver), intended for use in all EU member

states and EFTA countries, except in France and Italy where restrictive use applies.

In Italy the end-user should apply for a license at the national spectrum authorities in order to obtain

authorization to use the device for setting up outdoor radio links and/or for supplying public access to

telecommunications and/or network services.

This device may not be used for setting up outdoor radio links in France and in some areas the RF output

power may be limited to 10 mW EIRP in the frequency range of 2454 – 2483.5 MHz.

For detailed information the end-user should contact the national spectrum authority in France.

Norway — Do not operate the ABPM 7100 Bluetooth function in the geographical area within a radius of 20

km from the center of Ny-Ålesund.

United Arab Emirates

TRA

REGISTERED No:

ER40002/15

DEALER No:

DA44647/15

33 - Patient Information - operation of the ABPM 7100

Patient Information - operation of 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).

• When used on children, the device must only be applied with special care and under permanent

supervision.

• Turn off the device, remove the cuff, and notify the doctor in the event of experiencing pain, swelling,

redness or numbness in the limb where the cuff is placed. (It is expected that some mild to moderate

discomfort may be experienced during a blood pressure measurement.)

• Measurement can be interrupted at any stage by pushing a random button. This deflates the cuff and

the device can be removed.

Warning

Poor circulation caused by continuous cuff pressure.

• Do not kink the connecting tubing.

• If the patient has limited cognitive abilities, the device may only be used under supervision.

• Ensure the correct placement of the shoulder strap and cuff tubing.

• Always place the cuff tubing under the outer clothing (even at night).

• When used on children, the device must only be applied with special care and under permanent

supervision.

• Turn off the device, remove the cuff, and notify the doctor in the event of experiencing pain, swelling,

redness or numbness in the limb where the cuff is placed. (It is expected that some mild to moderate

discomfort may be experienced during a blood pressure measurement.)

Warning

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.

• Turn off the device, remove the cuff, and notify the doctor in the event of experiencing pain, swelling,

redness or numbness in the limb where the cuff is placed. (It is expected that some mild to moderate

discomfort may be experienced during a blood pressure measurement.)

Warning

If the patient is wearing an additional ME device on the same limb for monitoring purposes, the

placement and inflation of the cuff may trigger the temporary loss of the existing ME device’s

function.

The operation and use of the automated non-invasive blood pressure monitoring device may lead

to longer impaired blood circulation in the patient or respective limb.

• Turn off the device, remove the cuff, and notify the doctor in the event of experiencing pain, swelling,

redness or numbness in the limb where the cuff is placed. (It is expected that some mild to moderate

discomfort may be experienced during a blood pressure measurement.)

Warning

Poor circulation due to overly frequent measurements.

• If the patient has limited cognitive abilities, the device may only be used under supervision.

• Turn off the device, remove the cuff, and notify the doctor in the event of experiencing pain, swelling,

redness or numbness in the limb where the cuff is placed. (It is expected that some mild to moderate

discomfort may be experienced during a blood pressure measurement.)

Patient Information - operation of the ABPM 7100 - 34

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

Risk of injury caused by incorrect application of the cuff.

• If the patient has limited cognitive abilities, the device may only be used under supervision.

• When used on children, the device must only be applied with special care and under permanent

supervision.

• Ensure that neither the shoulder strap nor the cuff tubing can ever wrap around the patient’s neck.

Always place the cuff tubing under the outer clothing (even at night).

• 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.

• Turn off the device, remove the cuff, and notify the doctor in the event of experiencing pain, swelling,

redness or numbness in the limb where the cuff is placed. (It is expected that some mild to moderate

discomfort may be experienced during a blood pressure measurement.)

Attention

Damage to device

• Do not open the casing. Once the device is opened, all warranties will lapse.

Attention

Damage to device

• Do not wear the ABPM 7100 while showering. If you suspect that liquid has entered the device while

cleaning or using it, the device shall no longer be used on the patient.

• In the device was exposed to moisture, switch off the device and remove the batteries.

• The device may not be operated around MRI scanners or in the immediate vicinity of other medical

electrical equipment.

• During a defibrillator discharge, the device shall not be in contact with the patient. Such a discharge

may damage the ABPM 7100 and cause it to display incorrect values.

• Measurement can be interrupted at any stage by pushing a random button. This deflates the cuff and

the device can be removed.

Attention

Measurement errors

• Although the ABPM 7100 fulfills all EMC standard requirements, it should not be exposed to any

strong electromagnetic fields, as this may lead to malfunctions outside the limit values.

• The cuff tubing between the ABPM 7100 and the cuff may not be knotted, compressed or pulled

apart.

• The cuff connection must always engage with an audible “CLICK”. A loose connection between the

tubing and the device leads to measurement errors.

Note

• Severe malfunctions are indicated by a continuous beep.

• In the event of a continuous beep, switch off the device, remove the cuff and inform

your doctor.

24-hour measurement

1. Before a 24-hour measurement, go through these instructions together with your doctor.

2. Let your doctor explain possible hazards in detail on the basis of the warnings above.

3. Ensure that you have understood all functions and observable points.

4. Turn the device off when it is not being worn (e.g. during x-ray screening at airports). When the device

is applied again, ensure that it is turned on with the ON/OFF button.

EN

35 - Patient Information - operation of the ABPM 7100

Safety:

For your own safety during the following steps, please observe the safety instructions at the

start of this chapter.

Position of the cuff

It is imperative that the artery symbol is positioned on the brachial artery. If the cuff is aligned correctly, the

metal bar will lie on the outside of the upper arm (on the elbow side), whereby the fabric bag must cover the

skin under the metal bar.

The Buttons

ON/OFF

The

ON/OFF

button turns on and off the ABPM 7100 when the button is pressed for more

than 2 seconds.

START

The

START

button serves to

•

initiate the automatic protocol.

•

trigger a measurement in addition to the automatic protocol.

DAY/NIGHT

The

DAY/NIGHT

button is used to differentiate between waking and sleeping phases

during the measurement. Press the

DAY/NIGHT

button immediately before going to bed

and upon waking.

EVENT

Press the

EVENT

button to record an event which may affect the blood pressure and to

trigger an additional measurement. Note the reason for pressing the

EVENT

button in the

event log.

Measurement process

During the first measurement, the cuff is inflated in increments, to determine the cuff pressure required to

measure the systolic blood pressure value. This maximum required inflation pressure is stored and applied

by direct inflation during the subsequent automatic measurements. The patient should stay calm during the

measurement process, until the measurement is completed. Allow your arm to hang loose, or place your

lower arm loosely on the table or on a support whilst sitting. Avoid any movement! In the event of a failed

measurement a new measurement is performed automatically according to the measurement process

described above.

Cancelling a measurement

A measurement will be cancelled by pressing any buttons during the measurement process causing the cuff

to be quickly deflated automatically. The LCD display will then show “-

StoP-

” and the ABPM 7100 will beep 5

times. This cancellation will be stored in the measurement value table under

Cancel

.

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Welch Allyn ABPM 7100 Directions For Use Manual

Welch Allyn ABPM 7100 Directions For Use Manual

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