Braemar ER900 User manual

Braemar, Inc.
ER900
ER900ER900
ER900
and
andand
and
ER900 AF
ER900 AFER900 AF
ER900 AF
Arrhythmia Event Monitor
Caution: U.S. Federal law restricts this device to sale by or on
the order of a physician.

Braemar Limited Warranty
Braemar products are warranted to be free from manufacturing and
material defects for a period of one (1) year from the date of shipment
from Braemar to the original purchaser.
Excluded from this warranty are expendable supply items including, but
not limited to, electrodes, leadwires, patient cables and batteries. This
warranty does not apply to any product that Braemar determines has been
modified or damaged by the customer.
Except for the express warranties stated above, Braemar disclaims all
warranties including implied warranties of merchantability and fitness.
The stated express warranties are in lieu of all obligations of liabilities on
the part of Braemar for damages, including but not limited to, special
indirect or consequential, arising out of or in connection with the use or
performance of Braemar products.
Any action for breach of warranty shall be commenced within one (1)
year of said breach or be forever barred. Any repairs made to the product
that are not covered by the warranty shall be billed to the customer.
Document Number: 600-0603-00
Revision: J
Date: December 2008

ER900 and ER900 AF Event Monitors
1
Table of Contents
Overview...................................................................................................3
Indications for Use....................................................................................3
Precautions...............................................................................................3
Monitor Components ................................................................................4
Setup Steps ..............................................................................................5
Notes about Monitor Preparation:.............................................................5
Monitor Preparation (done by trained Technician) ...............................6
Electrode Application and Patient Hookup................................................9
Patient Operating Instructions ................................................................10
This page intentionally left blank.............................................................12
Troubleshooting......................................................................................13
Event Markings.......................................................................................14
Service & Maintenance ....................................................................... 15
Cleaning .................................................................................................15
Service....................................................................................................15
Service Items & Accessories ..................................................................15
Equipment Symbols................................................................................16
Specifications .........................................................................................18
Electromagnetic Emissions.....................................................................19
Electromagnetic Immunity ......................................................................19
Recommended Separation Distances ....................................................22
ER900 and ER900 AF Event Monitors
2
This page intentionally left blank.

ER900 and ER900 AF Event Monitors
3
Overview
The ER900 and ER900 AF Event Monitors are battery operated, solid
state, looping event recorder designed to record infrequent and elusive
heart arrhythmias. Event recording is activated by the patient or by
automatic event detection.
The ER900 provides up to 30 minutes of total recording time and will
operate for up to 30 days with two AAA Alkaline batteries.
Four pre-programmed recording options are available. Other selectable
options include audible event record, lead loss detect, pacer detect, X3
transmission, and automatic record on arrhythmia detect. Arrhythmias
detected include Bradychardia, Tachycardia, and Pause. The ER900 AF
includes all of these features and an in addition, Atrial Fibrillation.
Once an event is recorded, patients transmit their ECG
transtelephonically (over the telephone). All events are time-stamped.
Indications for Use
The device is indicated for diagnostic evaluation of patients who
experience transient symptoms such as; dizziness, palpitations, syncope,
or chest pain. The device is intended to record cardiac activity associated
with these infrequent and transient symptoms. Once data is recorded,
patients transmit the recorded ECG data over the telephone or directly to
a host PC for review by a licensed physician.
Precautions
A. Patient leads must be removed from electrodes before defibrillation.
B. Observe local laws for disposal of alkaline batteries.
C. Do not leave the batteries in the recorder when it is not in use.
Damage from corrosion could result.
D. Patient should be instructed to avoid close proximity to heavy
electrical equipment or other sources of electromagnetic interference.
E. Use of rechargeable batteries is not recommended.
F. Monitor is not for use with infants.
G. No automatic analysis algorithm can replace data review by a
qualified physician. Review and confirmation of analysis results is
required.
ER900 and ER900 AF Event Monitors
4
Monitor Components
Components
Necklace To attach, remove battery cover, insert necklace T’s
in slots in case. Replace battery cover.
Belt clip To attach, snap the monitor into the belt clip with
patient cable oriented up and the display facing out.
Patient Cable To adjust, move plastic slip rings up or down to
keep leads together. To lengthen, pull leads apart.
Program Mode Open battery compartment, remove batteries, and
set the programming option switches.
Batteries Insert two 1.5V AAA Alkaline batteries into the
compartment. Observe polarity symbols.

ER900 and ER900 AF Event Monitors
5
Setup Steps
This manual is designed to allow a technician to follow the instructions
page by page to setup the ER900 and ER900 AF monitor. Here is the
general layout:
1. Prepare monitor for recording.
A. Erase all previous events.
B. Choose/Setup program you want to use.
2. Connect leads and electrodes to patient.
3. Connect patient cable to monitor.
Notes about Monitor Preparation:
A. Use only a single channel cable with this monitor
B. Lead loss is on all the time. There is not a way to turn this
feature off.
C. If the monitor loses patient contact during a recording, the
monitor will produce an audible sound of the event until the
recording is complete. There are no exceptions or settings to
change this behavior
D. ARRHYTH switch turns Brady, Tachy, Pause, and Atrial
Fibrillation on or off as a group.
E. The Arrhythmia settings are pre-defined as follows
Brady Rate: 45 BPM
Tachy Rate: 140 BPM
Pause: 3.0 Sec
ER900 and ER900 AF Event Monitors
6
Monitor Preparation (done by trained Technician)
1. Remove the patient cable. Open the battery compartment by
removing the battery door. Set the programming option switches for
your desired options according to the following table.
Note: Use only a straightened paper clip to change the switch
settings. The up position is ON.
Switch Label Definition
1,2 PRE/POS
(Switch 1)
PRE/POS
(Switch 2) Pre/Post Time (sec)
Off Off 45/15
On Off 60/30 (default)
Off On 90/45
On On 240/60
3 SOUND Audible
On On (default)
Off Off
4 PACEMK CH1 Pacemaker Detect
On On
Off Off (default)
5 ARRYTH Arrhythmia Detect
On On
Brady <40
Off Off (default)
6 MEMLIM Memory Limit
On 3 events
Off 30 minutes (default)
7 TXRATE Transmission rate
On 3X (default)
Off 1X
8 (Unused)

ER900 and ER900 AF Event Monitors
7
Monitor Preparation (continued)
2. The patient cable should not be installed at this time. Install two
fresh AAA Alkaline batteries. Observe proper battery polarity.
Upon completion of the self-test the monitor will sound one of the
following tones:
Single Beep
(followed by)
Action
Falling tone Insert patient cable. (Will be followed by a
single beep and rising tones.) Go to step 3.
Rising tone Insert patient cable. Go to step 3.
Rising tone
and a phone
ring
Press RECORD/SEND button for two seconds.
Any previously recorded events will be
transmitted. Listen for a falling tone at the end
of the transmission. Insert patient cable. (Will
be followed by a single beep and rising tones.)
Go to step 3.
3. The monitor at this point is ready for recording. See Electrode
Application Section.
ER900 and ER900 AF Event Monitors
8
This page intentionally left blank.

ER900 and ER900 AF Event Monitors
9
Electrode Application and Patient Hookup
The Monitor Preparation section must be completed before proceeding.
1. Proper preparation of the patient's skin is absolutely essential for
obtaining a quality ECG recording. The skin surface where the
electrodes will be placed should be cleaned with alcohol, allowed to
dry, and abraded.
A. It is recommended that trained medical personnel instruct the
patient in the proper application of electrodes.
2. For each electrode: Snap electrode onto lead wire, remove the
protective backing from the adhesive, then apply electrode per
Electrode Placement diagram in this below or as instructed by the
physician.
A. Use good quality long term electrodes. Braemar recommends
the use of low impedance Holter electrodes. Instruct the patient
to apply fresh electrodes regularly. (Usually on a daily basis.)
3. Connect patient cable to the ER900 monitor.
A. A single beep should be heard when a proper connection is
made to the patient with a one channel cable.
B. Any loose electrodes need to be replaced.
4. The monitor is now looping and ready to record.
White (-)
Red (+)
ER900 and ER900 AF Event Monitors
10
Patient Operating Instructions
The ER900 or ER900 AF monitor should be ready when you receive it
from the technician. If there are any problems, refer to the
Troubleshooting section.
To Hookup:
1. Snap lead wires onto electrodes first then apply electrodes according
to physician instructions.
2. Insert the patient cable into the recorder.
A. The monitor will make a single beep for a good connection.
3. Reapply fresh electrodes daily.
4. The monitor is now looping and ready to record.
To Record: Events to be recorded will be described by the physician.
1. Press the RECORD/SEND button for two seconds until an audible
tone is heard, then release.
A. There are two RECORD/SEND buttons, you only need to push
one of them for two seconds to activate the monitor.
B. To stop a recording, press the RECORD/SEND button again for
two seconds.
2. Hold as still as possible during recording but continue breathing.
3. The recording is complete and ready to send when a phone ring is
heard from the monitor.
Automatic Record:
If Arrhythmia Detection is ON and an event is detected, the monitor will
beep at the start of the recording. The recording is complete and ready to
send when a phone ring is heard from the monitor.
A. The last event location is always reserved for a manual
recording.

ER900 and ER900 AF Event Monitors
11
To Send:
1. Remove the patient cable from the monitor.
2. Set the monitor on a flat surface with the speaker hole up.
3. Call the receiving center.
A. Cell phones and VOIP phones do not work for the transmission.
4. Follow receiving center instructions.
A. When instructed, place the telephone mouthpiece over the
monitor speaker hole.
B. Push the RECORD/SEND button for two seconds. The monitor
will make audible tones while the recording is being sent.
C. A falling tone will sound when the transmission is complete.
D. Pressing RECORD/SEND for two seconds during transmission
will stop the transmission. Pressing RECORD/SEND again will
re-transmit the recording.
5. When instructed that the events have been sent successfully, it is OK
to erase events by reinserting patient cable. (You will then hear a
rising tone.)
Erase Events:
1. Complete the “To Send” section above first.
2. Insert the patient cable. You will hear a rising tone.
3. The monitor is now looping and ready to record new events.
ER900 and ER900 AF Event Monitors
12
This page intentionally left blank.

ER900 and ER900 AF Event Monitors
13
Troubleshooting
Symptom Recommended solution
Install batteries or check battery direction.
Ensure patient electrodes/leads are connected to
patient properly.
Ensure patient cable is inserted completely.
Use only a one channel cable.
No single beep when inserting
patient cable
Lead loss is in off position, call technician.
Memory full-Phone Ring. Follow instructions To
Send and Erase Events.
Ensure patient cable is inserted completely.
Will not record
Ensure RECORD/SEND button is held for two
seconds.
Siren (alternating) tone while
recording
There is not a good connection. Check that
electrodes/leads have a good connection to patient
and cable is plugged into monitor
Phone ring sound every minute for
10 minutes
Memory is full, follow instructions To Send and
Erase Events.
Phone ring sound when
RECORD/SEND button is pushed
Memory is full, follow instructions To Send and
Erase Events.
Phone ring sound once An event is already stored in memory at start up,
also heard at the end of a recorded event. Follow
instructions To Send and Erase Events.
Three beeps every five minutes
with cable inserted
Batteries are low. Replace batteries and/or clean
battery contacts
Make sure mouthpiece of phone is directly over
monitor speaker
No information received by
receiving center
Ensure RECORD/SEND button is held for two
seconds.
Mouthpiece of phone must be close to the monitor
speaker hole.
Check telephone connection. Listen to phone line
before sending event(s) to ensure there is no noise.
Have patient call back and send ECG again.
Noise artifact on recorded ECG at
receiving center
Have patient try another phone.
Electrodes must be securely attached to patient.
Patient should remain still while recording.
Replace patient cable. Pulling on lead wires may
damage cable.
Verify the recording did not take place near a source
of electromagnetic interference (fluorescent lights,
computer monitors, or household appliances).
Noise artifact on recorded ECG at
patient location
Move electrodes slightly to the right or left of the
original location.
All or groups of timestamps for
recordings are the same.
If the inadvertent loss of power occurs, all the
timestamps in the FSK will reset to the time the unit
powered back up. Subsequent recordings will have
time stamps relative to the power up time.
Falling tone Transmission complete
Rising tone Ready to record
ER900 and ER900 AF Event Monitors
14
Event Markings
The following shows typical event markings that are generated by the
monitor and appear on the receiving station strip chart.

ER900 and ER900 AF Event Monitors
15
Service & Maintenance
Cleaning
Remove the batteries before cleaning the recorder. Clean the battery
terminals with a soft dry cloth. Dampen a soft cloth with mild detergent
and water to clean the recorder, lead wires, and belt clip.
Remove any adhesives from the patient lead wires with an adhesive tape
remover solution or swab. Use a mild disinfectant. Do not use alcohol
or acetone on the lead wires since they could stiffen and the insulating
plastic could crack.
Reinstall batteries and battery cover when done.
Service
If there is a problem with the monitor, review the problem descriptions
and solutions listed in the Troubleshooting section. If additional
assistance is required, contact customer service via phone, Fax or E-mail
listed below. Call customer service before returning a recorder to make
shipping arrangements.
•Note there isn’t any preventative inspection or maintenance that
can be performed by the end user.
Service Items & Accessories
Description Part Number
Patient lead, 1 channel, shielded 350-0173-09
Monitor belt clip / Holster 100-1764-002
Necklace 350-0180-00
Operator manual 600-0603-00
AAA I.E.C. LR03 Alkaline Battery 200-2492-001
ER900 and ER900 AF Event Monitors
16
Equipment Symbols
Symbol Description
Type B Applied Part
Consult manual.
SN Serial Number
0086
Complies with the Medical Device Directive of the
European Union.
Waste Electrical and Electronic Equipment (WEEE)
It is the responsibility of the end user to dispose of
this equipment at a designated collection point for
recycling.
Date of Manufacture
Manufacturer:
Braemar, Inc.
1285 Corporate Center Drive, Suite 150
Eagan, MN 55121 USA
Phone: [phone]
651.286.8620
Fax: [phone]
E-mail: [e-mail]
Web: http://www.braemarinc.com
Authorized European Rep:
QNET BV
Hommerterweg 286
6436 AM Amstenrade
The Netherlands

ER900 and ER900 AF Event Monitors
17
Additional equipment classification information as required in EN 60601-1
A. EQUIPMENT not suitable for use in the presence of a
FLAMMABLE ANAESTHETIC MIXTURE WITH AIR of WITH
OXYGEN OR NITROUS OXIDE
B. IPX0 Ordinary Equipment (enclosed equipment without protection
against ingress of water)
C. Internally Powered Equipment
D. Mode of Operation - Continuous Operation
ER900 and ER900 AF Event Monitors
18
Specifications
Functional
Number of ECG channels 1
Number of events 30 maximum
Sample rate 256 samples per second
User interface LED/Speaker
Memory
Max event time 30 minutes
Max total record time 30 minutes
Type Flash
Data retention Non-volatile
Physical
Dimensions 3.30"x 2.12"x .71"
(83.8mm x 53.8mm x 18.0mm)
Weight with batteries 3.5 oz.
Enclosure Molded plastic
Operating position Any orientation
Electrical
Input impedance 2M min.
CMR ratio 70dB
AC signal range +/- 3mV
DC signal range +/- 300mV
Resolution 23uV (8bits)
Frequency response .05Hz to 40Hz
Environmental
Operating temperature 0°C to +45°C
Non-operating temperature -20°C to +65°C
Operating humidity 10% to 95% (non-condensing)
Non-Operating humidity 5% to 95%
Transtelephonic Transmission
Transmit carrier 1900Hz
Carrier deviation 100Hz/mV
Battery
Type (2) AAA Alkaline IEC-LR3
Life 30 days min. during looping recording
Remove batteries during storage
Warranty 12 months from shipment

ER900 and ER900 AF Event Monitors
19
Electromagnetic Emissions
Emissions test Compliance Electromagnetic
environment - guidance
RF emissions
CISPR 11
Group 1 The ER9xx uses RF energy only
for its internal function. Therefore,
its RF emissions are very low and
are not likely to cause any
interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B The ER9xx is suitable for use in
all establishments, including
domestic establishments and those
directly connected to the public
low-
voltage power supply network
that supplies buildings used for
domestic purposes.
Electromagnetic Immunity
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
ER900 and ER900 AF Event Monitors
20

ER900 and ER900 AF Event Monitors
21
ER900 and ER900 AF Event Monitors
22
Recommended Separation Distances
Refer to the following table for recommended separation distances
between the ER9xx and portable and mobile RF communications
equipment.
The ER9xx is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The user of the ER9xx
can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and the ER9xx as recommended below, according to the
maximum output power of the communications equipment.
Separation distance according to
frequency of transmitter
Rated maximum
output power of
transmitter
W
150 kHz
to 80 MHz
d= 1.2 √P
80 MHz
to 800 MHz
d= 1.2 √P
800 MHz
to 2,5 GHz
d= 2.3 √P
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 rated at a maximum output power not listed above,
the recommended separation distance din metres (m) can be
estimated using the equation applicable to the frequency of the
transmitter, where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE1: At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.

Braemar Inc.
Phone: [phone]
1285 Corporate Center Drive, Suite 150 Fax: [phone]
Eagan, MN 55121 USA E-Mail: [email protected]
Copyright 2006, Braemar Inc. All rights reserved