Atria 3100 and 6100 Operating Instructions Rev C

This manual contains instructions for both the Atria 3100 and the Atria 6100.

Copyright © 2006 Cardiac Science Corporation All rights reserved. Cardiac Science Corporation 3303 Monte Villa Parkway Bothell, Washington 98021-8969 Customer Service 800-777-1777 or 425-402-2694 Technical Support 800-333-7770 or 425-402-2693

0086

Authorized Representative per MDD 93/42/EEC MDSS GmbH Schiffgraben 41 30175 Hannover, Germany

Table of Contents Intended Use... v Warnings... v Definitions of Symbols Used... vi

Chapter 1

General Information... 1-1 Inspection at Delivery... 1-1 General Description... 1-1 Interpretive Analysis Program... 1-2 Using Multiple Electrical Apparatus... 1-3 Password Protection... 1-3 Help Menu... 1-4 Automatic Information Entry... 1-4 Paperless Workflow... 1-4

Chapter 2

Equipment Setup... 2-1 External Connections... 2-1 Patient Cable... 2-3 Powering the Atria On and Off... 2-3 Charging the Battery... 2-4 Loading Recording Paper... 2-5

Chapter 3

User Interface... 3-1 Keyboard... 3-3 Display Atria 6100... 3-7 Display Atria 3100... 3-10

Chapter 4

User Settings... 4-1 Overview... 4-1 Setup Menu... 4-2 Print Setup Report... 4-2 ECG Settings... 4-2 Waveform Preferences... 4-7 Rhythm... 4-9 Patient Settings... 4-11 Directory Settings... 4-12 System Settings... 4-13

Chapter 5

Communications Setup... 5-1 Equipment Connections... 5-2 Grounding... 5-3 Network Setup... 5-3 External Printer Setup... 5-8 Setup Fax... 5-10 Setup Email... 5-10 Setup EMR Communications... 5-12

Atria Electrocardiograph Operating Instructions

1

Chapter 6

Patient Preparation... 6-1 Overview...6-1 Patient Preparation...6-2 Skin Preparation...6-2 Sensor Application...6-3 Resting ECG Lead Placement & Coding Chart...6-4 Disposable Resting ECG Sensors...6-5 Reusable ECG Sensors...6-6 Connecting Cables and Lead Wires...6-8 Alternative Lead Placements...6-8

Chapter 7

Acquiring ECG Reports... 7-1 Acquiring a Stat ECG...7-1 Recommended Workflow...7-1 Acquiring an ECG Using Pediatric Lead Placements...7-3 ECG Reports...7-3 ECG Tips...7-4 Change Recorder Speed, Gain, Frequency Response...7-5 Acquiring a Rhythm Report...7-6 Acquiring an ECG Using Alternative Lead Placements...7-6 Patient Demographics...7-7

Chapter 8

Patient Records... 8-1 Working with Patient Records...8-1 How to Display a Patient Record...8-2 Communications Options...8-7

Chapter 9

Sample Printouts... 9-1 Print Directory Report...9-2 Setup Report...9-3 Standard 12-Lead, 4-Channel ECG, Brief Statements...9-5 Standard 12-Lead, 6-Channel ECG, Brief Statements...9-6 Standard 3-Channel Rhythm & Manual ECG...9-7 Measurement Matrix...9-8 Median Complex, Brief Statements...9-9

Chapter 10

Troubleshooting... 10-1 Basic Troubleshooting...10-1 Trace Problems...10-2 Printing...10-4 Recognizing and Reducing ECG Artifacts...10-5

Chapter 11

Maintenance and Service... 11-1 Once per Shift...11-1 Annually...11-3 Component Replacement...11-3 Notice to Responsible Service Personnel...11-7 Performance Disclosures...11-7 EMC Declaration Tables...11-10 Technical Specifications...11-14

Chapter 12 2

Measurement Matrix... 12-1

Atria Electrocardiograph Operating Instructions

Intended Use Under the supervision of a qualified physician trained in ECG interpretation the Atria electrocardiograph can be used to record the electrical activity of the heart for the purpose of correlating the resultant waveforms with the health of the heart muscle tissue structures. This equipment produces a resting 12-lead electrocardiogram which can be used as a first step for assessment of patients with cardiac arrythmias, intraventricular conduction block, pre-excitation syndrome and ischemic heart disease. Records stored and used during the life of the patient can assist physicians in the diagnosis and natural history of heart related illnesses (such as coronary artery disease). This equipment is not designed to produce a definitive interpretation nor exhaustive evaluation of the patient’s heart but rather provide an effective beginning for evaluation of patients with heart abnormalities.

Warnings WARNING

!

Shock hazard. Do not touch the Atria or patient during defibrillation. Otherwise, serious injury or death could result.

WARNING

!

Burn Hazard. Severe burns may result from improper placement of defibrillator paddles. Never position defibrillator paddles close to or over ECG sensors. Remove all chest sensors (V-Leads/ C-Leads) from the patient before defibrillation. Read and follow all defibrillator instructions before attempting defibrillation.

WARNING

!

Operator or Patient Injury. Before performing procedure with the Atria, read and follow all safety procedures.

Caution

!

U.S. Federal law restricts this device to sale by or on the order of a physician.

Atria Electrocardiograph Operating Instructions

v

Definitions of Symbols Used

! !

Warning. Indicates serious injury or death hazard. Caution. Indicates potential equipment damage or minor injury hazard. Danger! High voltage. Hazardous voltage. Defibrillation-Protected Type CF Equipment. Equipotentiality (used to label the grounding lug). Alternating Current (AC). Direct Current (DC). Automatic Operation. Manual Operation. On/Standby. Stop Function. Modem port. Ethernet port. USB port. Serial port. Analog port. Indoor, dry location use only. No serviceable parts inside.

vi Atria Electrocardiograph Operating Instructions

Manufacture date Manufactured for

0086

Meets or exceeds Council Directive 93/42/EEC, MDD, Class IIa. Certified for both the U.S. and Canadian markets, to the applicable U.S. and Canadian safety standards. Component is certified for both the U.S. and Canadian markets, to the applicable U.S. and Canadian safety standards. Device or component is certified for the Japanese and/or Asian markets.

Atria Electrocardiograph Operating Instructions vii

viii Atria Electrocardiograph Operating Instructions

Quick Steps Atria Electrocardiograph Connect Patient Refer to the lead placement chart.

Precordial Lead Positioning

Power On Press

.

Acquire a STAT ECG Press

two times.

V1

Add Patient Demographics (to Stat ECG) 1.

Select Edit Demographics from ECG Review menu.

2.

Press

3.

Enter patient information.

4.

Press

V4

1.

Select Print Copy of this ECG.

2.

Press

V6

V1 Fourth intercostal space at right margin of sternum

V2 Fourth intercostal space at left margin of sternum

.

V3 Midway between position V2 and position V4

Acquire ECG with new Patient Info

V4 Fifth intercostal space at

junction of left midclavicular line

1.

Press

2.

Select Enter New Patient.

3.

Press

4.

Enter patient information.

5.

Press

.

V5 At horizontal level of position V4 at left anterior axillary line

.

V6 At horizontal level of position V4 at left midaxillary line

then

.

Limb Lead Placement

For a Continuous Rhythm Print Out . to stop rhythm printing.

User 1 and User 2 Selection Press

+

for User 1.

Press

+

for User 2.

RA

LA

Help Menu Press

V5

to ECG Review menu.

Print a Copy of ECG (from ECG Review menu)

Press

V3

.

Note: Certain demographics changes prompt to reanalyze and print.

Press

V2

+

RL

LL

(See opposite side for keyboard quick reference)

RA

Above inside right wrist

LA

Above inside left wrist

RL

Above inside right ankle

LL

Above inside left ankle

Power On

General Printing (Depends on ECG sequence setting.)

Press

to power ON.

Start a New Patient 1.

Press

to return to the main display.

2.

Press

to start a new patient.

3.

Press

to acquire and print an ECG.

Press

to print an auto rhythm report.

Press

to print a manual rhythm report.

Press

to end the printout.

Press

to advance one sheet of paper.

Press

to stop any of the above functions.

.

Manage Patient Records Press

for options.

Press

to scroll through options:

Navigation

• View Patient Directory • Enter New Patient: Enter patient information for future ECG recording • Print All New ECGs: Print all unprinted ECGs • Print Directory: Print list of saved records • Show Directory Status: Number of unprinted or demographiconly records (Some items may not be listed, depending on previous actions) • Delete All Records

Select Leads Press

Press

or

or

or

to select the lead

Press

to return to the main display.

Press

to scroll to the previous item in a list.

Press

to scroll to the next item in a list.

Press

to accept the current selection (or to select an item for editing).

Press

to return to the previous menu or display.

Press

or (Atria 6100 only)

triplet indicated on the key (for rhythm display and printouts). Press

or

to move the cursor within an edit field.

to select user-defined leads (Custom Lead 1 and

Custom Lead 2, respectively). The selected leads will be printed on manual

Send Records Press

rhythm and auto rhythm reports.

for send record options.

Select desired options: • Send All New or Selected ECGs • Select Records to Send NOTE: Communications option must be installed and configured to use this feature.

Change Settings Press

to change current speed setting.

Press

to change current gain setting.

Press

to change current artifact filter setting.

Press

to add a calibration pulse to the printout (manual or auto

Configure System Settings Press

to configure system settings.

Use the navigation buttons to select the Setup category.

Help

rhythm printouts only)

Press

+

to view the Help menu and print out help pages.

Show Sensor Status (Atria 3100 only) Press

Bothell, Washington

98021-8969

U.S.A.

• (608) 764-1919

to display status of sensors.

073-0159-00 E

Chapter

1

General Information

Inspection at Delivery Please inspect the Atria for any shipping damage. •

If the Atria was damaged during shipment, contact your shipping agent.

•

If an item is missing, contact your local representative or call Customer Service at (800) 777-1777 or (608) 764-1919.

WARNING

!

Misdiagnosis, equipment damage, and warranty void. Only use approved accessories and cables. Using non-approved accessories or cables may cause increased electromagnetic emissions, damage the Atria, or void the warranty.

General Description Figure 1-1 Atria 6100 Electrocardiograph Select ec Send/R

Right

us Previo

Left

Back

Setup X

Next

Home ry

Directo

1

! | || |||

3 # V123

2 @ RLF

5 % 1

4 $ V456

2

I

Help

V

A

C X Z

.

É

M '

Alt

y

On/Stb

Stop Manual Rhythm

Alt

ECG

Shift

-

/

_

Shift

Ã

Form Feed

i

J B

Å

Enter L

K Ö

J H G

F

P

Ñ

Y T

R D

S

Delete

) 1mV

O Ü

U

E

U Q

0

( Hz

9

8 * mm/mv

7 & mm/s

‘

t

Patien

6 ^

Auto Rhythm

Figure 1-2 Atria 3100 Electrocardiograph

Atria Electrocardiograph Operating Instructions

1-1

1 General Information

•

Battery or AC operation

•

Atria 3100: 2 x 40 character backlit LCD screen Atria 6100: 640 x 480 backlit color LCD screen

•

Thermal printer using 8.5 x 11, Z-fold paper

•

Manual and automatic rhythm mode

•

Standard or Cabrera lead format recording

•

Stores (and analyzes on interpretive models) waveforms acquired during automatic mode

•

Prints over 300 pages in manual mode at 25 mm/s with fully charged battery

•

Battery continuously recharges while connected to AC power (except during printing)

•

Selectable patient demographics

•

Relative ECG trace gains of x1/2, x1, x2 (corresponds to 5, 10, and 20 mm/mV printer gains)

Interpretive Analysis Program WARNING

!

Misdiagnosis. U.S. Federal law restricts this device to sale by or on the order of a physician. The Atria must only be used by qualified operators and any results interpreted by a qualified diagnostician.

The Atria is available with an optional University of Glasgow interpretive analysis program. Features include: •

Factoring in Age, Gender, and Race More than 500 measurements are factored into each analysis. Criteria for abnormalities include age, race, and gender. Race, for example, is key in identifying hypertrophy and T-wave abnormalities.

•

User-selectable QTc Formulas for diagnosis and pharmaceutical studies To calculate QTc, select from Hodges, Bazett, Fridericia, or Framingham formulas.

•

Retrospective Analysis Support The Atria reanalyzes data after age, gender, race, drug therapy, or clinical classification are changed.

Refer to the ECG Interpretation Criteria Physician’s Guide for complete information.

1-2 Atria Electrocardiograph Operating Instructions

Using Multiple Electrical Apparatus

Using Multiple Electrical Apparatus WARNING Shock hazard. Connect the Atria only to non-medical equipment compliant with IEC 60950 or 60601-1.

!

In addition, the enclosure leakage current of non-medical equipment connected to the Atria must not exceed 150µA in fault condition. If necessary, use an additional isolating transformer or floating power supply to maintain a proper enclosure leakage current and provide additional protection.

WARNING

!

Patient safety. Non-medical equipment connected to the Atria must not be within the patient’s vicinity: 6 feet (1.83 m) beyond the perimeter of the bed, table, or chair, and 7 1/2 feet (2.29 m) above the floor.

WARNING

!

Misdiagnosis. Electromagnetic interference may cause trace noise or input overload conditions. This may be caused by the presence of strong EMI fields, or generated by RF noise on the line power, or by electronic, surgical, or diathermy instruments in close proximity to the Atria. Position the Atria away from other electrical or electronic equipment, if possible. If used with, or around, other electrical or electronic equipment, always carefully monitor initial readings to verify normal operation. The Atria is compliant with IEC 60601-1-2 EMC immunity requirements. Refer to “EMC Declaration Tables” on pg. 11-10.

To prevent excessive patient leakage current ensure all patient equipment meets certified IEC and ANSI/AAMI medical standards. NOTE: The Atria patient leads are electrically isolated from ground and the device meets IEC and ANSI/AAMI medical standards for leakage current.

Password Protection The Atria uses password protection to restrict administrative and directory access. For more information on enabling and setting the password, see “Password Protection” on pg. 4-1.

Atria Electrocardiograph Operating Instructions

1-3

1 General Information

Help Menu To access the Help menu: 1. Press [ALT] + [H]. 2. Use the navigation keys to select a topic and then press [Select] to print topic information. NOTE: Help is available at any time except during alphanumeric entry (for example, when entering the patient’s name).

Automatic Information Entry To quickly enter user definable lists such as directory listings and email addresses type in the first few letters. To quickly access Atria menu items use the associated quick key for the item. For example, to select the menu item Print, press the letter [P] on the keyboard.

Paperless Workflow Paperless mode requires the following settings: •

Communication options must be installed and configured.

•

Set Auto Print to OFF.

•

Set Auto Send to ON.

Refer to “Communications Setup” on pg. 5-1 to configure communication options. Refer to “Sequence” on pg. 4-5 to configure Auto Print and Auto Send.

1-4 Atria Electrocardiograph Operating Instructions

Chapter

2

Equipment Setup

External Connections Equipotential Ground The Atria Electrocardiograph is considered CLASS II (ungrounded) equipment. The exposed metal on the Atria is not likely to become energized because all the exposed metal is double insulated from the internal live circuitry (i.e., will not become energized under single fault conditions). As a result, it is safer not to connect the exposed metal to the internal chassis or the functional earth of the Atria. This method of protection is recognized by all national and international consensus standards and safety agencies. Since the exposed metal in the Atria cannot become energized by any fault of the internal live circuitry and cannot become energized as a result of differences in the ground potential (because the exposed metal is not connected to ground via any Protective Earth conductor), then there is no reason to provide voltage equalization. Therefore, the equipotential ground contact is not connected to the exposed metal.

Input Power WARNING

!

Patient shock. The Atria must only be used with a medical grade power cord connected to medical grade AC outlet.

WARNING

!

Trip hazard. Route all cables away from main work areas to minimize risk of tripping and injury.

WARNING Shock hazard. Connect the Atria only to non-medical equipment compliant with IEC 60950 or 60601-1.

!

In addition, the enclosure leakage current of non-medical equipment connected to the Atria must not exceed 150µA in fault condition. If necessary, use an additional isolating transformer or floating power supply to maintain a proper enclosure leakage current and provide additional protection.

Atria Electrocardiograph Operating Instructions 2-1

2 Equipment Setup

WARNING Misdiagnosis. Using unshielded or excessively long cables may cause or increase susceptibility to electromagnetic interference.

!

Always use the shortest possible shielded cables.

Caution

!

Equipment damage. The Atria must be operated only at the line voltage and frequency specified on the external medical grade power supply (part number: 010-1684-00).

The input power cable includes a 3-conductor, medical grade power cable. Using the two power cables supplied, connect line power, in the following order: 1. Connect the external power supply (part number: 010-1684-00) to the External Power Connector (labeled C, below) on the back of the Atria. 2. Connect the AC power cable to the external power supply. 3. Connect the AC power cable to a properly grounded, medical grade wall outlet. Figure 2-1 Back Panel

A

B

C

Key A

Equipotential grounding

Connect equipotential ground cable here. (See “Equipotential Ground” on pg. 2-1.)

B

Power indicator

The green LED indicates the Atria is connected to AC power.

C

External power connector

Connect cable from power external power supply here. NOTE: The Atria does not have an AC power switch. To shut off AC power, unplug the Atria from the AC outlet.

NOTE: For communication connections refer to “Communications Setup” on pg. 5-1. 2-2 Atria Electrocardiograph Operating Instructions

Patient Cable

Patient Cable Figure 2-2 Front View

Connect the patient cable via connector on the front of the Atria. Ensure the connector on the cable is arrow-side-up then firmly push the connector until the arrow point is aligned with the edge of the Atria.

Powering the Atria On and Off Power On Press [On/Stby] to power on the Atria. The Atria performs self-tests and displays the following: •

Current date and time

•

Self-test errors

After completing self-tests, the Atria displays the Home screen.

Standby Mode The Atria must be connected to AC power to go into Standby mode. At any time during operation, press [On/Stby]. NOTE:

The internal battery charges in Standby mode.

Power Off To power off the Atria completely, disconnect the AC power cord and then press [On/Stby]. The automatic power down feature may be temporarily turned off by changing the battery saver setting. For more information, see “Battery Saver Mode” on pg. 4-14. NOTE: Automatic power down is disabled when the Atria is connected to a patient. Atria Electrocardiograph Operating Instructions

2-3

2 Equipment Setup

Power Indicator A green light on the back of the Atria (see Figure 2-1 on pg. 2-2) is on whenever the Atria is receiving power from the external power source.

Charging the Battery Caution

!

Data loss. The battery pack must be installed at all times for proper operation.

During normal operation, the following power indications are displayed:

Display

Action

Description

AC

Indicates the Atria is connected to none AC power.

Bat

Indicates the Atria is not connected none to AC power and is running on the battery.

Low

Indicates the Atria is running on battery power and less than 15 minutes of operating time remain. The Atria also beeps every 30 seconds as an audible low battery warning.

Power down

Indicates the battery no longer has Connect the Atria to AC power to enough power to maintain normal resume operation. operation and shuts off 5 seconds after the message is displayed.

2-4 Atria Electrocardiograph Operating Instructions

When Low displays, immediately connect the Atria to AC power to recharge the battery and prevent operation interruption.

Loading Recording Paper

Loading Recording Paper Caution

!

Warranty void. Using unapproved recording paper may damage the Atria and void the warranty. The Atria is intended for use only with approved ECG supplies.

Use only the following approved, thermal ECG paper: •

Assurance™, permanent trace, Z-fold. Guaranteed image integrity for 25 years when stored per manufacturer’s specifications.

•

HeartLine™, standard trace, Z-fold. Guaranteed image integrity 5 years when stored per manufacturer’s specifications.

To Load Paper Figure 2-3 Atria Paper Tray Removed

1. Remove the paper tray door on the left side of the Atria. a. Squeeze paper door lever, in the middle of tray, until it clicks. b. Pull out door completely, taking care not to drop the door. 2. Place a stack of paper into the compartment so that the black queue mark on the lower left corner of the paper is visible. 3. With your right hand, lift the top sheet of paper. 4. Align the door on the track, and slide the door most of the way into the unit. DO NOT INSERT THE DOOR AT AN ANGLE. 5. Pull the paper so it covers the door. NOTE: The edges of the paper must be parallel to the lines printed on the paper door. Atria Electrocardiograph Operating Instructions

2-5

2 Equipment Setup

6. Slide the door into place until it clicks. 7. Press [On/Stby] to power on the unit and then wait until the unit beeps. 8. Press [Form/Feed] three to five times. Ensure the paper is tracking straight. If the paper is not straight: •

Press form feed a couple more times.

•

Repeat this procedure paying careful attention to the alignment.

9. Tear off extra pages at the perforation. NOTE: The correct paper type must be selected. The default paper setting is Assurance. If using HeartLine paper, see “Paper Type” on pg. 4-13 to change the setting.

2-6 Atria Electrocardiograph Operating Instructions