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Operating Instructions

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3. W d 1 2VP d 1 2VP d 2 3VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 12 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 manufacturer range applies people For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter NOTE1 At 80 MHz and 800 MHz the separation distance for the higher frequency NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and Atria Electrocardiograph Operating Instructions 11 13 11 Maintenance and Service Technical Specifications Dimensions Weight unit only Display Keyboard Data Storage Input Power Battery duration Printout Printout device Paper dimension Paper type Chart speeds Gain Printout formats Acquisition Lead selection Modes Frequency response Input impedance Electrode offset tolerance Sampling Artifact filter response Storage Pacemaker display capability Interpretation optional 11 14 Atria Electrocardiograph Operating Instructions 15 0 x 13 125 x 5 5 381mm x 334mm x 140mm 11 Ibs 5 kg including external power supply Atria 3100 2 x 40 character backlit
4. Aw 9 SISA BUY x 993 5 AydoujuadAy anp JS 8A SUO8JX3 AudoujuadkAy Je naiaju8 e qeqoud 4 S4 wy SNUIS EE SIX SU pz uo saedsi su 292 BAJSHUI su OLE 1 RAUB pu su 9g uo14eang SW Opl 8AJ84u su 999 06 yey 4 10 910 I 10 540 1 I dH uos suiyuer Jg 55215 2113HNI0 5 54934 LP 961 50 51 8 0 0 79 1601 Gl 29 9 9 Atria Electrocardiograph Operating Instructions 9 Sample Printouts 9 10 Atria Electrocardiograph Operating Instructions Chapter 10 Troubleshooting This chapter lists common problems and recommended solutions For additional questions contact Cardiac Science Technical Support at 800 777 1777 or 608
5. 2 1 Patient Cable oae eee e AR AE ot tees deu 2 3 Powering the Atria On and 2 3 Charging the secre rae CREER XA US 2 4 Loading Recording Paper 2 5 Chapter 3 User Interface iit nb ote rw COUP eis del Keyboard 5 ode Rane oy MEO S 3 3 Display Atria 6100 3 7 Display Atria 3100 nm ene T een 3 10 Chapter 4 User SCHINES 5 od accus ens KE e aed OVERVIEW voro Rea de t e Mae da ec n 4 1 Setup Menu aue cob S e paw OR RE URDU eae 4 2 Print Setup Report ee ce eee deme e RR dd 4 2 ECG Sctungs v oer wu ee st eS 4 2 Waveform Preferences dor pua UNA A ERN 4 7 Rhythm c sexe ha Au e eee secet en prc e P Ce 4 9 Patient Settings 2 44 n espe t itu hp ace ids 4 11 Directory Settings tint nee awd 4 12 System Settings s 54 Mewes wales awe eee MUN WE Vh 4 13 Chapter 5 Communications Setup 5 1 Equipment Connections 5 2 gad Seek 5 3 Network rU anda aed 5 3 External Printer Setup SF ULLA REUS 5 8 e d b cod i 5 10 Set p Email 66M SH RERO ue Eb S 5 10 Setup EMR Communications 5 12 Atria Electrocardiograph Operati
6. 6 1 Working with Patient Records 8 1 How to Display a Patient Record 8 2 Communications Options 8 7 Sample Printouts 9 1 Print Directory Report 9 2 Setup REPOR ae anne mins Mae fo RAS 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 amp Manual ECG 9 7 Measurement Matrix 9 8 Median Complex Brief Statements 9 9 Troubleshooting 10 1 Basic Troubleshooting 10 1 Trace Problems eene PEREAT 10 2 Printing oiv EAR 10 4 Recognizing and Reducing ECG Artifacts 10 5 Maintenance and Service 11 1 Shift iussu RUBRI Ree EX E RE a 11 1 Annually iussis veLU EU EROS PUR Y Be 11 3 Component Replacement 11 3 Notice to Responsible Service Personnel 11 7 Performance Disclosures 11 7 Declaration Tables vs eR oe 11 10 Technical Specification
7. Atria Electrocardiograph Operating Instructions 8 8 8 Patient Records Record Status Detail Hold Hold Prevents sending the record if Send All New or Selected ECGs is selected Prevents auto deletion of the record Delete Record Deletes the selected patient record Caution A Data loss Deleting a patient record permanently removes the record Once deleted a record can not be recovered Enter New Patient To create one or more patient files prior to recording any ECGs use the Enter New Patient selection in the directory This feature allows you to input demographics into the directory in advance of taking an ECG which later reduces the time required to acquire the report 1 Press Directory 2 Press Next to scroll to Enter New Patient 3 Press Select 4 The DisplayMenu gt Edit Patient Data display appears Enter the patient s ID number last name first name date of birth gender and as many other fields as required or as time will allow Atria automatically creates a file for the patient Print Directory To print all patient records currently stored in the directory select the Print Directory option in the directory 1 Press Directory 2 Press Next to scroll to Print Directory 3 Press Select Atria prints all the records in the directory see sample printout in Chapter 9 8 4 Atria Electrocardiograph Operating Instructions How to Display a Patient
8. Shift U Keyboard V2 Hold down AIt and Shift then press U to step through the settings U U grave U U acute 0 circumflex umlaut Keyboard V2 Hold down Alt then press to step through the settings grave 6 circumflex 6 0 tilde 6 umlaut Alt Shift O Keyboard V2 Hold down Alt and Shift then press U to step through the settings O O grave acute circumflex 6 O tilde umlaut AIt P Keyboard V2 forward slash A Keyboard V1 colon Atria Electrocardiograph Operating Instructions 8 5 3 User Interface Function Special Characters Key A Keyboard V2 Hold down Alt then press A to step through the settings a grave a acute a circumflex a a tilde a a umlaut a a ring Description Shift A Keyboard V2 Hold down AIt and Shift then press A to step through the settings A A grave A A acute A A circumflex A A tilde A A umlaut A A ring Alt S R German double s Keyboard V2 colon L Keyboard V2 single quote mark Alt Shift L double quote mark Keyboard V2 Alt Z _ underscore Alt X back slash
9. Class 2 Height This field will not appear if Class 1 is left blank or NORMAL UNKNOWN OTHER is selected Enter height using the units displayed Enter up to 3 numeric characters Range 0 96 in or 0 244 cm 7 8 Atria Electrocardiograph Operating Instructions see CLASS 1 list above text entry Patient Demographics Weight Enter weight using the units displayed Enter up to 3 numeric characters Range 0 550 Ib or 0 249 kg text entry Systolic BP Enter the systolic blood pressure limit Enter up to 3 numeric characters Range 0 250 text entry Diastolic BP Enter the diastolic blood pressure limit Enter up to 3 numeric characters Range 0 250 text entry Department Enter a department number to identify your department within a facility Enter up to 5 numeric characters Range 1 32000 text entry Room Enter a room number to identify your location within a facility Enter up to 7 alphanumeric characters text entry Technician Enter the name of the technician who acquired the ECG Enter up to 20 alphanumeric characters text entry Physician Enter the name of the patient s physician Enter up to 20 alphanumeric characters text entry User Field A user defined field You may label this field see Patient Settings on pg 4 11 A possible use might be to identify the referring
10. C Keyboard V1 forward slash C Keyboard V2 C c cedilla Alt V comma Alt Shift V lt less than Alt period Alt Shift B gt greater than Keyboard V1 single quote mark Keyboard V2 fi n tilde Alt Shift N N tilde Keyboard V2 M dash 3 6 Atria Electrocardiograph Operating Instructions Display Atria 6100 Display Atria 6100 The Atria 6100 display has two types of screens the Home screen and various menu screens WARNING Misdiagnosis Do not use Atria screen images for diagnosis The screen image is provided for reference only Use the printout to ensure accurate diagnosis Atria 6100 Home Screen After the Atria is powered up it performs self tests and then displays the Home screen NOTE Press Home from most menu screens to return to the Home screen Figure 3 3 Atria 6100 No Name No Id Home Screen Stable 40 Hz AG 25 mm s 10 mm mV Q User 1 Label Text Description A Name and ID Displays name and ID number for current patient If there is not a current patient this field displays as No Name No Id and pressing ECG results in STAT ECG B Heart rate Indicates heart rate Atria Electrocardiograph Operating Instructions 8 7 3 User Interface Label Text C S
11. 1297764 Iner Deborah ID Atria Electrocardiograph Operating Instructions 9 7 9 Sample Printouts Measurement Matrix PR ee ey VU SPE UMN RUE IU cus S4 DIDICIHTSIN PS EE 5 1 4 SU pc 10015299510 10 su cog 210 su OLE 10 su 98 uo1 e4NG SUD SU Opi su 999 MM 06 USA 92 0 6 9002111180 Sug3A LP yOluepsujy u28 sul yuar ug 55212 21434010 5 334 p96licolzl 8 0 0 941601 QI yeuogag 29 9 8 Atria Electrocardiograph Operating Instructions Median Complex Brief Statements Median Complex Brief Statements H SL 318U1S UIU0UU U0ISV 4 181188 160 89 15 516090024194 3u 0019 eae
12. 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 Power On Press QUE Acquire a STAT ECG Press rcc two times Add Patient Demographics to Stat ECG 1 Select Edit Demographics from ECG Review menu 2 Press 3 Enter patient information 4 Press to ECG Review menu Note Certain demographics changes prompt to reanalyze and print Print a Copy of ECG from ECG Review menu 1 Select Print Copy of this ECG 2 Press Acquire ECG with new Patient Info 1 Press i rain 2 Select Enter New Patient 3 Press Parra E 4 Enter patient information 5 Press rca then eo For a Continuous Rhythm Print Out Manual Press D Manual Press Ston to stop rhythm printing User 1 and User 2 Selection Press for User 1 Press for User 2 Help Menu Press Precordial Lead Positioning V4 Fourth intercostal space at right margin of sternum Fourth intercostal space at left margin of sternum V3 Midway between position V5 and position V4 Vi Fifth intercostal space at junction of left midclavicular line Vs At horizontal level of position V4 at left anterior axillary line Ve At horizontal level of position
13. 6 2 4 i RLF 123 V456 mm s E Dy Manual Auto Fhythm S Rythm Atria 6100 o im c fj Patient fp Directory A Setup sensors er N 1 2 3 4 5 6 7 8 9 0 DUNS Vac ANT Simy ns o Delete lt Enter S 1 ons yal LINE cm Atria 3100 Key A Display Atria 6100 Includes ECG Settings B Navigation keys C Menus D Keyboard E Power F ECG Keys G Sensor Atria 3100 only 3 2 Atria Electrocardiograph Operating Instructions Keyboard Keyboard Function Main Power The following table describes the Atria keys NOTE Not all key functions are available on every screen Key On Stby Description Powers on the Atria When the Atria is on press this key to Power off the Atria when operating on battery power Go to Standby when connected to external power The battery continues to charge User At the Home screen Alt 1 or 2 Select either User 1 or User 2 See Multiple Users on pg 4 1 ECG Press Stop at any time stop printing and return to the Home screen ECG Acquire and print a 12 lead ECG a series of reports using pre programmed lead sequences and settings Auto Rhythm Print an auto rhythm report a rhythm strip with a pre selected number of pages using the leads currently selected Manual Rhythm Print a
14. 764 1919 Basic Troubleshooting PROBLEM PROBABLE CAUSE The Atria will not power up The Atria is not connected to external power refer to Back Panel on pg 2 2 for connection information Battery is not installed or has no charge Faulty power cord AC outlet not functional Faulty external power supply The Atria beeps twice or emits abnormal Function or key is not allowed for beeping sounds example the end of a list or field is reached The Atria has frozen The Atria does not Press and hold the On Stby key for respond to key strokes and the display five seconds or until the Atria shuts off does not change To continue with normal operation press On Stby again to restart the Atria The Atria display is completely blank Press the On Stby key to restart the Atria If no response verify the Atria is plugged in and press On Stby again The Atria is in maintenance mode On Stby key was pressed twice when powering on Press the On Stby key once to restart the Atria Contrast is too light or dark Press Form Feed to verify the Atria is on and then press Shift Previous to lighten the display or press Shift Next to darken the display Atria Electrocardiograph Operating Instructions 10 1 10 Troubleshooting PROBLEM PROBABLE CAUSE The Atria will not send records via Verify the Atria is connected to a phone
15. Displays up to three rhythm lead selections based on the 12 lead format selected 4 2 Atria Electrocardiograph Operating Instructions ECG Settings ECG Menu Items Report Format Description Selections Report Format 12 lead Select the format to use for the report generated by pressing the ECG button For sample printouts see Chapter 9 STANDARD 4 CHANNEL 3 channel ECG with 1 rhythm lead STANDARD 3 CHANNEL e STANDARD 3 3 3 channel ECG with rhythm leads STANDARD 6 CH 5S LD 5 seconds per lead 1 page total STANDARD 6 CH 10S LD 10 seconds per lead 2 pages total CABRERA 4 CHANNEL 1 rhythm lead CABRERA 3 CHANNEL CABRERA 3 3 3 channel ECG with 3 rhythm leads CABRERA 6 CH 5S LD 5 seconds per lead 1 page total CABRERA 6 CH 10S LD 10 seconds per lead 2 pages total STANDARD 4 CHANNEL STANDARD 3 CHANNEL STANDARD 3 3 STANDARD 6 CH 5S LD STANDARD 6 CH 10S LD CABRERA 4 CHANNEL CABRERA 3 CHANNEL CABRERA 3 3 CABRERA 6 CH 5S LD CABRERA 6 CH 10S LD Rhythm Lead Channel 1 This selection displays for the following formats only 4 channel 3 3 format The rhythm lead displays at the bottom of the printout LEAD LEAD Il LEAD Ill aVR aVL aVF V1 V2 V3 V4 V5 V6 aVR Atria Electrocardiograph Operating Instructions 4 3 4 User Settings ECG Menu Items Description Selections R
16. ECG Menu Description Selections Interpretation Preferences Analysis Select the format for the Analysis Statements BRIEF Statements BRIEF Displays minimal explanations in mixed case FULL for example Normal ECG FULL Displays longer explanations in upper case for example NORMAL ECG Also includes reason statements Print Enables analysis statements on the original copy of the ON Interpretation on ECG report printout OFF Original Print Enables analysis statements on additional copies of the ON Interpretation on printed ECG report OFF Copies Bradycardia Heart rates below the set adult rate limit are labeled text entry Limit Bradycardia Rate limit range is 41 to 69 Tachycardia Heart rates above the set adult rate limit are labeled text entry Limit Tachycardia Rate limit range is 81 to 129 NOTE Tachycardia limits are age dependent for neonatal and pediatric patients For neonatal and pediatric patients the Atria interpretive software disregards the Tachycardia Limit setting and uses predefined limits between 100 and 180 depending upon age For more information see Chapter 3 Heart Rate in the Physician s Guide QTc Formula Select the QTc formula it displays at the bottom of the ECG printout For additional information on the QTc formulas see QT Interval on page 4 3 of the Physician s Guide Hodges Default Bazett Fridericia Framingham 4 6
17. The Atria is compliant with IEC 60601 1 2 EMC immunity requirements Refer to EMC Declaration Tables on pg 11 10 WARNING Misdiagnosis Using unshielded or excessively long cables may cause or increase susceptibility to electromagnetic interference Always use the shortest possible shielded cables Overview Patient preparation consists of the following steps 1 2 3 Patient preparation See Patient Preparation on pg 6 2 Skin preparation See Skin Preparation on pg 6 2 Apply sensors For placement information see Resting ECG Lead Placement amp Coding Chart on pg 6 4 or Alternative Lead Placements on pg 6 8 For sensor specific instructions see Disposable Resting ECG Sensors on pg 6 5 or Reusable ECG Sensors on pg 6 6 Apply sensors and connect the patient cable and lead wires before entering patient information this allows the sensors to adhere stabi lize and improve conductivity See Connecting Cables and Lead Wires on pg 6 8 Atria Electrocardiograph Operating Instructions 6 1 6 Patient Preparation Patient Preparation The following steps are necessary for patient comfort and to minimize muscle artifacts Assure the patient there is no danger or discomfort involved Explain that full cooperation will produce a valuable diagnostic record Ensure the patient is comfortable and relaxed Lay the patient on a cot or padded table large eno
18. Trace Problems PROBLEM PROBABLE CAUSE Waveforms are flat for all leads and or OVERLOAD message will not clear Acquiring ECG too quickly Pressing ECG twice prevents the Atria from waiting for good data before printing ECG Press ECG one time only Faulty patient cable Electrical interference from an external source is causing noise spikes Waveform is flat for one or more leads all others are OK and or OVERLOAD message will not clear Baseline is drifting in waveform for one or more leads Acquiring ECG too quickly Pressing ECG twice prevents the Atria from waiting for good data before printing ECG Press ECG one time only Electrode is being pulled tapped or pressed Faulty lead wire s or patient cable Use of dissimilar sensors or sensors not recommended for use with the Atria Sensors need to sit longer on skin Trace is noisy The waveform is not a single clean line AC interference from lighting cables or equipment near patient Improper AC Mains Frequency setting in the System menu Improper Line Filter setting in Setup gt Waveform Preferences Occasional noise or artifact in the waveform for one or more leads Patient movement Muscle tremor noise Electrical interference Sensors need to sit longer on skin Ineffective Baseline Filter setting in Setup gt Waveform Preferences Incorrect heart rate printed and or dis
19. WARNING False readings The lead status check does not detect lead reversals Always ensure the correct lead placement is used for the lead configuration selected NOTE Deviations from the technical specification ranges listed can affect device performance The Atria is tested for IEC 60601 1 2 electromagnetic compatibility The failure criterion for the device is undetectable interference with the ECG trace which could result in misdiagnosis While the device passes the relevant standards it may exhibit evidence of interference when subjected to electrostatic discharges high voltage transients or high voltage surges as defined in IEC 801 2 IEC 801 4 and IEC 801 5 The interference from a single event will demonstrate as a sharp noise spike on the ECG trace The clinician will not confuse such a noise spike with the heart beat waveforms and there is no hazard of misdiagnosis In the unlikely situation the equipment is placed in an environment where such interference events are common either the equipment or the interference source may be moved Battery pack Under normal conditions a fully charged battery pack provides adequate power to print a minimum of 300 pages of data at paper speed of 25 mm sec or a minimum of 55 minutes of continuous acquisition and printing A fully discharged battery pack will completely recharge in approximately 6 hours Heart rate detection The Atria heart rate meter is specified to function i
20. at a point which is 3 8 of the ST T interval T AMP uV T wave amplitude T AMP UV T wave amplitude QRSAR uV ms Total area of the QRS complex divided by 20 TMORPH T wave morphology 4 TS T um RWNCH R wave notch count DWCON 96 Probability of the presence of a delta wave STSLOP degrees ST slope horizontal 0 TON ms Time from the beginning of the recording to the beginning of the T wave TDUR ms T wave duration total T DUR ms T wave duration QTINT ms QT interval NOTE Where ms is milliseconds and uV is microvolts 12 2 Atria Electrocardiograph Operating Instructions Index A AC mains frequency 4 14 AC power connect 2 2 acquire ECG 7 1 acquire rhythm printouts 7 6 add patient 8 4 administrative password 4 13 alternate chest lead acquire ECG 7 6 configure 4 10 placement 6 8 analysis options 4 6 artifact electrical interference 10 6 muscle 10 5 artifact filter change current 7 5 default setting 4 7 performance disclosure 40 Hz filter 11 9 automatic deletion 8 6 automatic information entry 1 4 B baseline filter 4 8 wander 10 6 wide 10 6 battery charging 2 4 testing 11 3 battery pack disclosure 11 8 battery saver setting 4 14 bradycardia limit 4 6 C cable patient cleaning 11 1 testing 11 3 cables connect 2 2 2 3 5 2 cabrera select custom 4 10 select standard 4 3 calibration pulse insert 3 3 change waveform settin
21. check the problem leads listed on the display Replace faulty electrodes if necessary Press Auto Rhythm or Manual Rhythm NOTE obtain an alternate chest lead ECG press ECG The printout will be in the current configured ECG format using the selected leads 7 6 Atria Electrocardiograph Operating Instructions Patient Demographics Patient Demographics A WARNING Misdiagnosis Some patient information directly affects ECG analysis Your patient s physician uses this information when interpreting ECG reports Likewise an interpretive Atria provides more accurate and complete analysis statements when you enter complete patient information Press Patient To enter a new patient select Enter New Patient and enter patient demographics To change an existing patient select View Patient Directory and select a patient from the list to Edit Demographics NOTE Recommended workflow is to enter patient information before acquiring an ECG since this information affects both physician analysis and computer analysis The patient demographic fields are described on the following pages Field Description Settings Patient ID Enter a unique identifier for the patient text entry 20 characters Last Name Patient last name text entry 20 characters First Name Patient first name text entry 20 characters Date Of Birth Enter Year 4 digits Month 2 digits Day text entry 2 digit
22. 8 6 Atria Electrocardiograph Operating Instructions Communications Options A Directory Full message displays if a new patient is started and all records in the directory do not meet any of the automatic deletion criteria A new record is allowed only if one of the following actions is taken Print at least one unprinted record Send at least one unsent record Atria with communication option only Acquire at least one demographics only record Delete at least one record from the directory When the directory is full you may however obtain ECG printouts These will not be stored in the directory unless storage space 1s available Communications Options Sending ECG Records to an EMR System NOTE Using the send feature requires the communications option See Communications Setup on pg 9 1 Use the send feature to send the record to either the EMR system or network share based on the EMR connection setting see Setup EMR Communications on pg 5 12 The Atria can send records in a batch or as all new records Follow the instructions under Send All New or Selected ECGs Alternatively you have can review each records to send In reviewing the send status for each record you have the option of placing individual records on hold which prevents the record from being sent until its status 1s changed again To send selected records only first follow the instructions under Select Records to Send t
23. Age Age Format Gender Race Medication 1 Medication 2 Class 1 Class 2 Height Weight Systolic BP Diastolic BP Department Select the local fields to display in the Enter New Patient ON CLEAR Room menu ON HOLD Technician OFF Physician User Field User Field Label Displays if User Field is ON CLEAR or ON HOLD text entry Backspace to clear the field and then enter up to 15 alphanumeric characters The User Field Label renames the User Field The new name is displayed when entering patient demographics and is printed on patient demographics reports The User Field may be used for anything For example use the field for the referring physician s name V3 Placement Pediatric recording of V4R only ON CLEAR ON HOLD OFF Comments Enter comments regarding the patient ON OFF Directory Settings The patient directory is always sorted by date with the most recent saved records at the top The field displayed for each patient may be selected as e View by ID e View by Name e View by Room 4 12 Atria Electrocardiograph Operating Instructions System Settings System Menu Items System Settings Use the System menu to set display preferences password protections and battery life settings Description Selections User 1 2 Select Selects either User 1 or User 2 After a new user is 1 selected the Atria must restart for the settings to take 2 effect System settings apply
24. ECG using alternate chest lead placement 6 8 Atria Electrocardiograph Operating Instructions Alternative Lead Placements Placement Options Acquire a standard 12 lead ECG according to the Resting ECG Lead Placement amp Coding Chart on pg 6 4 For the Alternate Chest Lead ECG retain the placement of the limb sensors Reposition the chest sensors using 6 of the placements described in the table Placement Options on pg 6 9 Configure leads as desired NOTE The lead configuration for the Alternate Chest Lead is completely customizable The example shown below is only one of many possible lead configurations See Custom Lead Settings on pg 4 9 for additional information NOTE Lead configuration may also contain any of the standard chest leads if desired Alternate Placement VaR C2R position V3R C3R position C4R position VER C5R position on right position on right V7 C7 position Vg Cg position Vg Cg position V7R C7R position CgR position position Figure 6 3 Description fourth intercostal space at right margin of sternum midway between position VaR and position V4R C4R fifth intercostal space at junction of right midclavicular line horizontal level with V4R at right anterior axillary line horizontal level with V4R C4R and VER C5R at right midaxillary line horizontal level with Vg Cg at posterior axillary line
25. For CUSTOM 3 CHANNEL format select leads for channels 1 through 3 For CUSTOM 6 CHANNEL format select leads for channels 1 through 6 LEAD LEAD Il LEAD Ill aVR aVL aVF V1 V2 V3 V4 V5 V6 aVR 4 10 Atria Electrocardiograph Operating Instructions Patient Settings Rhythm Menu Items Description Selections Setup Custom 1 and 2 Channels 7 For ALTERNATE CHEST LEAD 3X4 1R format select V1 through 12 leads for channels 7 through 12 V3 V4 V5 V6 V7 V8 V9 V2R V3R V4R V5R V6R V7R V8R VOR Patient Settings The Patient menu sets the patient demographic fields displayed when entering patient demographics NOTE The following fields affect waveform analysis Age Gender Race Medication and Class Demographic field options OFF disables a field The field does not display when entering patient demographics ONorON CLEAR enables a field and clears previously entered information The field displays when entering patient demographics ON HOLD enables a field and retains previously entered information The previously entered information is saved until the field is re entered Atria Electrocardiograph Operating Instructions 4 11 4 User Settings Patient Description Selections Menu Items Last Name Select the patient information fields to display in the ON First Name Enter New Patient menu OFF Date of Birth
26. GREEN RIGHT ARM RED LEFT ARM YELLOW CHEST WHITE RED CHEST WHITE YELLOW CHEST WHITE GREEN CHEST WHITE BROWN CHEST WHITE BLACK CHEST WHITE VIOLET IEC STANDARD LIMB LEADS SENSORS CONNECTED MEASURED LEAD L R LEAD II F R LEAD III F L AUGMENTED LIMB LEADS SENSORS CONNECTED MEASURED R and L F L and R F F and R L CHEST LEADS SENSORS CONNECTED MEASURED C and L R F and L R F and L R F C and L R F Cs and L R F Cg and L R F PLACEMENT OF THE CHEST SENSORS AHA V Fourth intercostal space at right margin of sternum Fourth intercostal space at left margin of sternum V Midway between position V5 and position V4 V Fifth intercostal space at junction of left midclavicular line Vs At horizontal level of position V4 at left anterior axillary line Ve At horizontal level of position V4 at left midaxillary line IEC Fourth intercostal space at right margin of sternum Fourth intercostal space at left margin of sternum C Midway between position and position C4 C 4 Fifth intercostal space at junction of left midclavicular line C At horizontal level of position C4 at left anterior axillary line C At horizontal level of position C4 at left midaxillary line PLACEMENT OF THE LIMB SENSORS 6 4 Atria Electrocardiograph Operating Instructions Disposable Resting ECG Sensors Disposable Resting ECG Sen
27. Insert the new battery into the battery compartment WARNING Fire or explosion hazard Use only an approved replacement battery pack Replace the battery pack only with the battery specified on the label inside the battery compartment Slide the connector onto the jack Ensure the plug 1s fully connected NOTE Ensure the connector is oriented correctly Do not force the connector onto the jack Slide the battery cover plate back into position slide the front tabs in first Reload the paper and the replace the paper tray cover see Loading Recording Paper on pg 2 5 Reconnect external power 11 6 Atria Electrocardiograph Operating Instructions Notice to Responsible Service Personnel Notice to Responsible Service Personnel The contents of this document are not binding If you find a significant difference between this service information and your Atria please contact Cardiac Science Technical Support We reserve the right to improve or modify products without amending this document or advising the user We recommend consulting authorized personnel for all service and repairs and using only approved replacement parts Cardiac Science Corp will not otherwise assume responsibility for material quality workmanship or any consequences thereof if approved replacement parts are not used This product has been carefully designed and manufactured to provide a high degree of safety and dependability However we can no
28. LCD screen Atria 6100 640 x 480 backlit color LCD screen Full alphanumeric keypad plus designated quick keys Atria 3100 50 records standard optional upgrade to 150 Atria 6100 150 records standard optional upgrade to 300 AC Operation 115 230 VAC x 1096 50 60 Hz 55 minutes continuous printing 216 mm thermal dot array 8 5 x 11 US letter 210mm x 300mm A4 Thermal sensitive Burdick Assurance or HeartLine paper recommended 12 5 25 50 mm sec 5 10 20 mm mV Chest or Limb may be split 3 4 6 or 12 channels additional rhythm formats I Il HII aVR aVL aVF V1 V2 V3 V4 V5 V6 and Alternate Chest Lead chest lead selection V2R through V9R V7 V8 and V9 Automatic automatic rhythm or manual rhythm Meets or exceeds ANSI AAMI EC11 1991 and IEC 60601 2 51 standards Meets or exceeds ANSI AAMI EC11 1991 and IEC 60601 2 51 standards i300 mV 8000 Samples Sec 2 5uV LSB 40 Hz 3db 500 samples second 2 5 LSB Meets or exceeds ANSI AAMI EC11 1991 standard and IEC 60601 2 51 Diagnosis measurements reasons statements based on five demographic criteria Technical Specifications Environmental Operating temperature Operating relative humidity Operating atmospheric pressure Storage temperature Storage relative humidity Storage atmospheric pressure Harmful Ingress of Water Input Output Units with communications Optional Upgrades Conforms to Standards Safet
29. Record Print All New ECGs To print all ECGs in the directory which have not been printed yet 1 e Record Status is not PR select the Print All New ECGs option in the directory 1 Press Directory 2 Press Next to scroll to Print All New ECGs 3 Press Select Atria prints all ECGs which have not printed previously Show Directory Status To view a sum of all unprinted unsent with the communications option or demographics only records use the Show Directory Status option in the directory OF ap Nou NOTE If Show Directory Status is not listed in the directory then the directory does not contain demographics only unprinted or unsent with the communications option records Press Directory Press Next to scroll to Show Directory Status Press Select Atria displays total number of unprinted records Press Next to display total number of demographics only records To print unprinted records scroll to Records to print and press Select twice Or scroll to ECGs to Acquire and press Select twice The list of records in the directory displays with the demographics only records listed first To send unsent records scroll to Records to send and press Select twice Atria Electrocardiograph Operating Instructions 8 5 8 Patient Records Delete All Records NOTE The below information is for use by authorized personnel only With Atria it is possible to delete all co
30. charger WARNING Fire explosion or contamination Properly dispose of batteries in accordance with local regulations Burning heating or improper disposal may cause explosion fire or contamination Caution Loss of data The battery pack must be installed at all times for proper operation Operating without a battery pack may result in lost data Caution Patient injury Do not remove the battery within the patient vicinity WARNING Shock hazard Verify the external power cord is disconnected before removing or replacing battery A blank display is not a reliable indication of disconnected external power gt BE gt 1 Disconnect external power 2 Pull out the paper tray and remove the paper 11 4 Atria Electrocardiograph Operating Instructions Component Replacement Figure 11 1 Atria Paper Tray and Paper Removed 3 Remove the battery cover plate a Slide the plate toward the front of the Atria b Lift up the back end of the plate to remove Figure 11 2 Removing Atria Battery Cover Plate Figure 11 3 Removing Atria Battery Cover Plate 4 Remove battery pack a Slide the battery pack out of the battery compartment b Disconnect the connector Atria Electrocardiograph Operating Instructions 11 5 11 Maintenance and Service AN AN Caution Equipment damage Do not disconnect the plug by pulling the lead wires This could cause loose or broken connections
31. modem fax function not working jack Verify the Atria contains an internal fax modem contact your local representative or Cardiac Science Corp Technical Support Department for assistance Verify the phone number and description fields are correctly filled in These are found in the Setup gt Send Receive gt Setup FAX menu item Verify the correct phone type and connection type are selected in the Setup gt Send Receive gt Setup FAX menu item Verify the phone cord is functioning The Atria displays Directory Full Records in the directory are either message demographics only have not been printed or have not been sent with the communications option See Automatic deletion when the Directory is full on pg 8 6 for more information All printouts show Alternate Chest Lead Custom 1 or Custom 2 is configured to ECG or RIGHT CHEST LEAD ECG Alternate Chest Lead Configure setting to any other format see Custom Lead Settings on pg 4 9 Trace Problems Before troubleshooting trace problems ensure the following Good quality electrodes are used The electrodes are not dried out The skin is properly prepared and the electrodes are applied correctly with good contact to the skin Electrodes are not dirty Lead wires are securely attached to all electrodes The ECG cable is securely plugged into the Atria 10 2 Atria Electrocardiograph Operating Instructions
32. print the measurement matrix using a saved patient record The Measurement Matrix consists of a column for each standard lead I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 The following table explains the numerical values in the Measurement Matrix NOTE Unless otherwise specified all times are in milliseconds and all amplitudes are in microvolts MEASUREMENT Units DESCRIPTION PON ms Time from the beginning of the representative beat to the beginning of the P wave PDUR ms P wave duration total QRSON ms Time from the beginning of the representative beat to the beginning of the QRS complex QRSDUR ms QRS duration QDUR ms Q wave duration RDUR ms R wave duration SDUR ms S wave duration R DUR ms R wave duration S DUR ms S wave duration P DUR ms P wave duration QRSDEF ms Intrinsicoid deflection time P AMP UV P wave amplitude P AMP P wave amplitude QRSP2P uV Peak to peak amplitude of the QRS complex QAMP uV Q wave amplitude RAMP uV R wave amplitude Atria Electrocardiograph Operating Instructions 12 1 12 Measurement Matrix MEASUREMENT Units DESCRIPTION SAMP S wave amplitude R AMP UV R wave amplitude S AMP UV S wave amplitude STAMP uV ST amplitude at J point 2 8STT UV ST amplitude at a point which is 2 8 of the ST T interval 3 8STT uV ST amplitude
33. rhythm reports for the selected lead group 1 through 4 for presets or 5 and 6 for custom settings Press Manual Rhythm or Auto Rhythm The Rhythm menu includes the following items Auto Rhythm Pages e Setup Custom 1 e Setup Custom 2 Setup Auto Rhythm Enter the number of pages for an Auto Rhythm Report 1 to 10 Custom Lead Settings The Atria has two custom lead configurations Custom 1 Custom 2 Both configurations are available when automatic rhythm or manual rhythm is selected WARNING False readings The lead status check does not detect lead reversals Always ensure the lead placement used is for the lead configuration selected Atria Electrocardiograph Operating Instructions 4 9 4 User Settings Rhythm Menu Items Setup Custom Description Selections 1 and 2 Set Up Custom 1 or 2 The custom lead format used for Auto Rhythm or Manual Rhythm Custom 1 is the default displayed lead set NOTE Selecting the ALTERNATE CHEST LEADS format will cause all standard ECG printouts to include alternate chest lead settings until another custom lead format is selected i e press any of the keys 1 through 4 CUSTOM 3 CHANNEL STANDARD LIMB 6 CHANNEL STANDARD PRECORDIAL 6 CHANNEL CUSTOM 6 CHANNEL STANDARD 12 CHANNEL CABRERA LIMB 1 3 CABRERA LIMB 4 6 CABRERA 6 CHANNEL CABRERA 12 CHANNEL ALTERNATE CHEST LEADS Channels 1 through 6
34. the Atria displays a message If necessary override the error message and continue recording by pressing the ECG key again for more information see Wait for good data on pg 4 5 NOTE If Wait for Good Data is set to ON in the ECG menu then it is possible to press ECG prior to connecting the patient The Atria waits until all leads are connected and the acquired ECG traces settle the Atria detects good data before automatically starting the ECG Change Recorder Speed Gain Frequency Response To temporarily change print settings for the current patient use the following shortcuts Key 7 Description Selections Select paper speed 12 5 mm s 25 mm s 50 mm s 8 Selects the ECG gain 5mm mV 10 mm mV 20 mm mV L10 C5 mm mV L20 C10 mm mV 9 Toggles the upper ECG filter frequency response 40 Hz 150 Hz NOTE The updated settings remain in effect until changed again or the Atria is restarted Atria Electrocardiograph Operating Instructions 17 5 7 Acquiring ECG Reports Acquiring a Rhythm Report The Atria does not save rhythm report data 1 Select the leads Keys 1 through 4 select preconfigured lead groups Keys 5 and 6 select user customized lead settings For more information see Custom Lead Settings on pg 4 9 Press Auto Rhythm to print a rhythm strip for a predefined number of pages See Rhythm on pg 4 9 Press Manual Rhyt
35. tracings NOTE If using a test subject be sure not to disturb the sensor site since common baseline artifact will occur This should not be confused as a broken wire Testing the battery The Atria automatically monitors battery status No additional battery tests or calibration are required If the battery does not retain a charge for more than 30 minutes of operation Refer to Battery on pg 11 4 WARNING Fire or explosion Never remove the battery pack and attempt to recharge using an external battery charger Annually A complete safety and component check must be performed annually by a qualified service technician The testing must include a 1 mV calibration pulse test to verify the gain hardware is properly calibrated Component Replacement The Battery and Patient Cable are the only user replaceable component on the Atria Atria Electrocardiograph Operating Instructions 11 3 11 Maintenance and Service WARNING Hazardous voltage The interior of the Atria may retain hazardous voltages even after the Atria is shut off and the power cord disconnected There are no internal user serviceable parts other than the battery Do not remove any other cover or try to disassemble the Atria If the Atria appears damaged immediately discontinue use and contact a qualified service technician Battery WARNING Fire or explosion Never remove the battery pack and attempt to recharge using an external battery
36. 1 diathermy instruments in close proximity to the Atria may cause trace 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 below The Atria is intended for use in the electromagnetic environment specified below Electromagnetic Emissions Emissions test Compliance Electromagnetic environment guidance flicker emissions IEC 61000 3 3 RF emissions Group 1 The Atria uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The Atria is suitable for use in all CISPR 11 establishments Harmonic emissions Class B IEC 61000 3 2 Voltage fluctuations Complies 11 10 Atria Electrocardiograph Operating Instructions EMC Declaration Tables Electromagnetic Immunity munity dest IEC 60601 Compliance Electromagnetic environment y test level level guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic discharge ESD 8 kV air 8 kV air tile If floors are covered with synthetic IEC 61000 4 2 material the relative humidity should be at least 3096 Electrical fast 2 kV for power 2 kV for power M
37. 11 connect to the 802 11 USB port The Atria emails ECG reports in pdf format 1 Press Home and then press Setup 5 10 Atria Electrocardiograph Operating Instructions Setup Email 2 Select Send Receive gt Email gt Enabled and complete the following entries a b SMTP Server Address enter in the format nnn nnn nnn nnn Email Comment enter ON to add an optional single line to the body of the email Sender Address enter the from address Email Reply to Atria 3100 or Reply to Address Atria 6100 to enter the address for replies For each email address enter the Email Destination Label and descriptions NOTE Email Address 1 is the default address See Auto Email on pg 4 5 3 Verify email operation a b Press Home then press ECG twice Select Email ECG and then select the email destination Verify the ECG email was successfully received Atria Electrocardiograph Operating Instructions 5 11 5 Communications Setup Setup EMR Communications Network setup is required in order to send records to an EMR system or a shared location on the network See Network Setup on pg 5 3 and Equipment Connections on pg 5 2 Set up Web Services Follow the instructions below to configure communication with an EMR system such as Heartcentrix or the Pyramis ECG Database Management system version 6 1 or later When the Atria is configured to commu
38. ARNING 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
39. Alpha characters 1 through 0 Numeric characters Delete Delete one character Enter Accept or edit the current selection Form Feed Advance one sheet of paper Special Characters Shift 1 exclamation point Shift 2 at sign Shift 3 pound sign Shift 4 dollar sign Shift 5 percent Shift 6 carrot Shift 7 amp ampersand Shift 8 asterisk Shift 9 left parenthesis Shift 0 right parenthesis 8 4 Atria Electrocardiograph Operating Instructions Keyboard Function Special Characters NOTE Donotenter European accented characters in any password for this device Key E Keyboard V2 Description Hold down Alt then press E to step through the settings e grave e acute e circumflex e umlaut Alt Shift E Keyboard V2 Hold down AIt and Shift then press E to step through the settings E E grave E E acute E E circumflex E E umlaut Alt Y Keyboard V2 Hold down Alt then press Y to step through the settings y y acute y y umlaut Shift Y Keyboard V2 Y Y acute Alt U Keyboard V2 Hold down Alt then press U to step through the settings grave circumflex umlaut
40. Atria Electrocardiograph Operating Instructions Waveform Preferences Waveform Preferences Configure the appearance of the waveform settings at power on Waveform Preferences Description Selections Menu Items Speed Set the chart paper speed 12 5 mm s 25 mm s 50 mm s Gain Set the waveform gain 5 mm mV 5 mm mV 10 mm mV 10 mm mV Default 20 mm mV 20 mm mV L 10 5 L 10 C 5 standard gain for limb leads half the L 20 C 10 standard gain for chest leads L 20 C 10 double the standard gain for limb leads standard gain for chest leads Artifact Filter Select the upper frequency response 150 Hz 150 Hz provides the most accurate recording and 40 Hz should be used when little or no noise is present NOTE The American Heart Association s 1990 Recommendations for Standardization and Specifications in Automated Electrocardiography Bandwidth and Signal Processing pertaining to high frequency response for both adult and pediatric recordings are met when using the 150 Hz setting 40 Hz reduces muscle artifact and high frequency environmental noise for a smoother trace but less fine detail This filter setting applies only to the printed report and displayed ECG The data analyzed by the measurement and interpretation software is not affected For additional information see 40 Hz Artifact Filter on pg 11 9 Atria Electrocardiograph Operating Instructions 4 7 4
41. HH UN H3QHO3H MOIGHNA Continued A eu pues dnjass pa qesig xeJ PUdS dnyas 03780510 NOLLYDINNWWOD OBULICD UOl OBULIO YW eAla0ay pUSS dn 3S pejgesig edA yuomyay uo j2auuo yJow eN SAre28M pues dnjas pc at cl 9002111180 abed 140933 97135 9 Sample Printouts Setup Report 9 4 Atria Electrocardiograph Operating Instructions Standard 12 Lead 4 Channel ECG Brief Statements Standard 12 Lead 4 Channel ECG Brief Statements 2160 90 15751 0900 8 AU 0019 OU Z EZ 20 ENG
42. Miller s preferences Dr Carrera prefers the Full format interpretation one copy of the ECG ECG speed of 25 mm sec and gain of 10 mm mV Select User 2 and enter Dr Carrera s preferences 1 To determine the current user Atria 3100 Press Setup The current user displays to the right of the menu title Atria 6100 The current user is shown in the lower right corner of the display 2 Press Home and then press Alt 1 to select User 1 or press Home and then press Alt 2 to select User 2 The Atria requires a restart to change users 9 Press any key to restart Password Protection Use a password to prevent unauthorized settings changes Refer to either Administrative Password on pg 4 13 Directory Password on pg 4 14 Atria Electrocardiograph Operating Instructions 4 1 4 User Settings Setup Menu The Setup menu includes the following 1tems Print Setup Report ECG Waveform Preferences Rhythm Patient Directory System Send Receive Printer Print Communication Log Print System Statistics Product Keys Service Functions To go to the Setup menu press Home and then press Setup NOTE Configure settings for either User 1 or User 2 Print Setup Report Prints all the settings for the current user ECG Settings The ECG menu includes the following items Report Format Sequence Interpretation Preferences Report Format
43. ORDS 1 2 3 4 Press Home Press Send Rec Select Get ECGs Specify the criteria for the orders NOTE Entries are not case sensitive a To receive all ECG records available up to the maximum directory size leave all fields blank b To receive all ECG records for a specific patient enter the patient ID MRN or patient name Press Send Rec After a few seconds the Atria displays a list of all ECG records that meet the criteria specified above Select the orders a To select all records hold down Alt and then press 1 b To de select all records hold down Alt and then press 2 c Toselect or de select individual records highlight the record and press Select Selected records display with a brace Atria 3100 or a checkmark Atria 6100 in front of the record Press Send Rec After a few seconds the Atria begins downloading the records and indi cates the progress of the download NOTE Ifthe Atria reports errors the communications log contains more information regarding the errors To print the communications log Press Setup and then select Print Communications Log For more information press ALT H to access the Help menu and select Troubleshooting gt Communications Atria Electrocardiograph Operating Instructions 8 11 8 Patient Records 8 12 Atria Electrocardiograph Operating Instructions Chapter 9 Sample Printouts NOTE The sample reports in t
44. Operating Instructions Atria 3100 Electrocardiograph Atria 6100 Electrocardiograph Part No 070 1167 00 Rev C a CARDIAC SCIENCE 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 Setet ernie Ale CEA ein RET ast Gita RS Warnings jk SLA En EE UI CM pU e eas Definitions of Symbols Used vi Chapter 1 General Information 1 1 Inspection at Delivery 1 1 General Description RR KE X RE she ies 1 1 Interpretive Analysis Program 1 2 Using Multiple Electrical Apparatus 1 3 Password Protection ota fos te RP 1 3 Help Menus tintin ERE M RR REP eed aie ne 1 4 Automatic Information Entry 1 4 Paperless Workflow 1 4 Chapter 2 Equipment Setup 2 1 External Connections
45. User Settings Waveform Preferences Menu Items Description Selections Baseline Filter Select the low frequency response STABLE Baseline Baseline Stabilization Filter Suppresses most baseline wander interference while providing an accurate ECG reproduction no distortion of the ST segment This filter applies to the printed report displayed ECG and the data analyzed 0 05 Hz Use the 0 05 Hz filter when signal delay is unacceptable NOTE Cardiac Science Corp recommends use of the STABLE Baseline filter except when a signal delay of 1 5 seconds is unacceptable NOTE Both the 0 05 Hz and STABLE Baseline selections meet the American Heart Association s 1990 Recommendations for Standardization and Specifications in Automated Electrocardiography Bandwidth and Signal Processing pertaining to low frequency response in electrocardiography STABLE Baseline 0 05 Hz Line Filter Filter electrical interference from AC line voltage ON NOTE The line filter should be on Turn off only if OFF necessary Pacer Displays pacemaker signals as artificial spikes on the ON Enhancement display and printouts the positive spike is at least 10 mm OFF Lead Group Select the lead triplet The selected leads print on the LIT manual rhythm and the auto rhythm reports RVF V123 V456 Custom 1 Custom 2 4 8 Atria Electrocardiograph Operating Instructions Rhythm Rhythm AN To print
46. V4 at left midaxillary line Limb Lead Placement RA Above inside right wrist gt Above inside left wrist KI p RL Above inside right ankle LL Above inside left ankle RL LL See opposite side for keyboard quick reference Power On General Printing Depends on ECG sequence setting Press to power ON Press O to acquire and print an ECG Start a New Patient Ps to print an auto rhythm report Press RI 1 Press to return to the main display Press mel to print a manual rhythm report 2 Press Patient to start a new patient Press stop to end the printout 3 Press Press to advance one sheet of paper Manage Patient Records Press stop to stop any of the above functions Press Directory for options Navigation Press to scroll through options Press to return to the main display View Patient Directory Enter New Patient Enter patient information for future ECG recording Press to scroll to the previous item in a list Print All New ECGs Print all unprinted ECGs Print Directory Print list of saved records Show Directory Status Number of unprinted or demographic only records Some items may not be listed depending on previ ous actions Press PARIE to accept the current selection or to select an item for editing Delete All Records Press Mi to scroll to the next item a list Press ETS to return to the previous men
47. a does not display the heart rate check the problem leads listed on the display Replace faulty electrodes if necessary Press ECG Use the navigation buttons to display Acquire ECG current patient data then press Select NOTE If patient demographics are in the process of being entered the Atria prompts to use those demographics for the ECG If not used the demographics are not saved NOTE The recorder speed gain and frequency response settings can be temporarily modified if necessary See Change Recorder Speed Gain Frequency Response on pg 7 5 7 2 Atria Electrocardiograph Operating Instructions Acquiring an ECG Using Pediatric Lead Placements Acquiring an ECG Using Pediatric Lead Placements In order to use pediatric lead placements the V3 placement feature must be enabled See V3 Placement on pg 4 12 To configure the Atria to always acquire ECGs using pediatric lead refer to ECG Settings on pg 4 2 1 Prepare the pediatric patient refer to Chapter 6 Patient Preparation Pediatric Chest Lead Placement on pg 6 8 2 Follow steps for Acquiring ECG Reports on pg 7 1 For V3 Placement select NOTE Inthe Edit Patient Data field change the Age Format to months and enter the patient s age in months or enter the Date of Birth and the Atria calculates the age automatically 3 Verify the patient s heart rate displays on the Home screen If heart rate does
48. act 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 A 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 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 AN 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 1s available with an optional Unive
49. ains power quality should be typical of a transient burst supply lines supply lines commercial or hospital environment IEC 61000 4 4 1 kV for 1 kV for input output input output lines lines Surge 1kv differential 1kv differential Mains power quality should be typical of a IEC 61000 4 5 mode mode commercial or hospital environment 2 kV common mode 2 kV common mode Voltage dips short lt 5 UT lt 5 Ur Mains power quality should be typical of a interruptions and lt 95 dip in lt 95 dip in commercial or hospital environment voltage variations UT for 0 5 cycle If the Atria user requires continued on power supply for 0 5 cycle 40 Ur operation during power mains interruptions input lines 40 Ur 60 dip in Ur then the Atria must be powered from an IEC 61000 4 11 60 dip in Ur T uninterruptible power supply or a battery for 5 cycles for 5 cycles 70 U o UT 30 dip in Ur 30 dip in Ur tor 25 cycle for 25 cycle lt 5 U 0 9 T REUT lt 95 dip in Ur lt 95 dip in UT for 5st for 5 sec Power frequency A m 3 A m Power frequency magnetic fields should be 50 60 Hz magnetic field IEC 61000 4 8 at levels characteristic of a typical location in a typical commercial or hospital environment NOTE 1 U1 is the a c mains voltage prior to application of the test level Atria Electrocardiograph Operating Instructions 11 11 11 Maintenance a
50. assword to restrict all directory options ON Password except Enter New Patient see Working with Patient OFF Records on pg 8 1 for a list of directory options When set to ON the system prompts for a password enter password up to 15 characters AC Mains Labels ECG records with the AC line frequency and 50 Hz Frequency selects the appropriate line filter See Line Filter on 60 Hz pg 4 8 Ensure the frequency selected is correct for your region Battery Saver When the battery saver mode is ON the Atria ON Mode automatically powers down after the interval set in the OFF Battery Saver Timeout field NOTE The battery saver mode is disabled when the Atria is connected to a patient Battery Saver Sets the number of seconds before the Battery Saver text entry Timeout Mode starts Maximum setting 999 seconds Keypad Revision Select the keypad revision Revision 1 Revision 2 Adjust Contrast Press Shift Previous or Shift Next to adjust Press Shift screen contrast anytime after power up Previous Next To continue press Select Waveform Grid Displays or hides the waveform grid ON Atria 6100 only OFF 4 14 Atria Electrocardiograph Operating Instructions Chapter 5 Communications Setup 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 o
51. ation file on the Atria Install the digital certificate on the Atria Configure the Atria to use the supplicant configuration 5 6 Atria Electrocardiograph Operating Instructions Network Setup CREATE A SUPPLICANT CONFIGURATION FILE On a PC use a text editor to create a configuration file a Follow the examples in the Wireless Network Custom Configuration Examples in the Atria help page or the WPA_supplicant Reference Manual on the CD b Specify the name and location of the digital certificate c Save the file with the name config NOTE Donot use a file extension for the configuration file d Copy the configuration file to a blank USB device INSTALL THE SUPPLICANT CONFIGURATION FILE 1 6 Insert the USB device containing the supplicant configuration file into the USB port on the back of the Atria Press Home and then press Setup Select Service Functions from the Setup menu The Atria displays a warning message press Enter Use the navigation keys to select Copy wpa supplicant cfg from usb and then press Enter The system copies the file and displays a message indicating the trans fer was successful Press On Stby twice to reboot the Atria INSTALL THE DIGITAL CERTIFICATE ON THE ATRIA 1 2 3 Export the required certificate to a file on a PC Use the pem format Copy the certificate file to a blank USB device Insert the USB device containing the c
52. ations company cause to request the user to disconnect the equipment User s should ensure for their own protection that the electrical ground connections of the power utility telephone lines and internal metallic water pipe system if present are connected together This precaution may be particularly important in rural areas CAUTION Users should not attempt to make such connections themselves but should contact the appropriate electric inspection authority or electrician as appropriate The LOAD NUMBER 5 assigned to each terminal device denotes the percentage of the total load to be connected to a telephone loop which is used by the device to prevent overloading The termination on a loop may consist of any combination of devices subject only to the requirement that the total of the Load Numbers of all of the devices does not exceed 100 SERVICE STATION If you have any questions or trouble please contact Cardiac Science Corp at 800 777 1777 or 608 764 1919 608 764 1919 i 1 8969 U S A 6 gt emm science Bothell Washington 9802 W
53. brillation 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 gt gt gt Defibrillation Protected Type CF Equipment Equipotentiality used to label the grounding lug Alternating Current Direct Current DC Automatic Operation Manual Operation On Standby Stop Function Modem port Ethernet port USB port D 2 Serial port Analog port Indoor dry location use only RY 9 No serviceable parts inside vi Atria Electrocardiograph Operating Instructions SA am El T 5 US Manufacture date Manufactured for Meets or exceeds Council Directive 93 42 EEC MDD Class 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
54. cian Immediately replace worn or damaged cables or sensors Before each use or at least once per shift Check the Atria cables and sensors for wear or damage This includes Atria housing Ensure the housing is clean and undamaged Check for dents bulges or cracks Power cords ncluding the plugs jacks and outlet Ensure the power cords are not worn or damaged Specifically check for loose cracked or bent connectors at the plug ends and cuts nicks or fraying of the cords Wall outlet Check the wall outlet for cracks or other damage Other cables and sensors Check all other cables and sensors for loose bent or cracked connectors and cuts nicks or fraying of the cords 11 2 Atria Electrocardiograph Operating Instructions Annually AN Testing The Atria performs a self test at power up No additional testing or calibration is necessary Check the Patient cable If the patient cable appears damaged in any way including nicks cuts bulging or fraying contact your local representative for replacement Visually inspect the cable for cracks stress marks and broken or bent pins Connect the patient cable to the ECG and attach each sensor lead to an electronic heart signal simulator If a simulator is not available a test subject may be used Check the signal transmission through the cable by flexing the cable and electrode lead wires and observing the ECG rhythm for irregular
55. diograph Operating Instructions Display Atria 6100 Figure 3 4 Atria 6100 Patient Source Selection Menu rw Jane Smith 999999999 Patient Source Selection Enter New Patient urrent Patient iew Patient Directory Sensors OK Stable 40 Hz 25 mm s Press Patient 10 mm mV User 1 If the Home screen is not displayed press Home Press Patient Press Select The Enter Edit Patient ID entry field displays Enter patient information and press Select The next entry field auto matically displays NOTE review or change an entry press the Back key to go to the Select Field to Edit menu Use Previous or Next and to scroll to a field and then press Select to enter or change the information When all demographic information is entered press Home to return to the Home screen Atria Electrocardiograph Operating Instructions 8 9 3 User Interface Display Atria 3100 The Atria 3100 display has two types of screens the Home screen and various menu screens Atria 3100 Home Screen After the Atria is powered up it performs self tests and then displays the Home screen NOTE Press Home from most menu screens to return to the Home screen Figure 3 5 Atria 8100 Q Home Screen No Name No Id 60 bpm press Sensors Q Q Label Text A Name and ID 9 Description Displays name and ID number for current patient If there is not a current patient t
56. e limb plate surface Apply the same amount of electrolyte to each sensor Place sensors firmly on the limb sites Choose fleshy areas above wrists and ankles Position so the limb plate will not press against the body or table when the patient is relaxed On arms the screws should point downward toward the feet On legs the screws should point upward toward chest Without stretching the strap wrap it around the limb until a hole lines up with a sensor ear Then stretch the strap and fasten it with the next hole Connect the limb leads to the four limb plates Applying Welsh bulb chest sensors Caution Patient skin irritation Welsh bulb sensors may contain nickel a material that can cause skin irritation Monitor the electrode site and if irritation occurs use an alternate electrode Connect the 6 Welsh bulb sensors to the V leads C leads on the patient cable Locate the 6 V lead C lead positions on the patient s chest see Rest ing ECG Lead Placement amp Coding Chart on pg 6 4 Squeeze out a drop of Signa gel electrode gel at each sensor site Use a tongue depressor to spread the electrolyte ensure it does not touch the electrolyte from another site Apply the sensors by squeezing the rubber bulb and allowing suction to hold the sensor in place Only a small dimple should remain on the bulb when it is released Ensure the leads conform to the body contours and no strain is placed on the senso
57. e low battery warning Power Indicates the battery no longer has Connect the Atria to AC power to down enough power to maintain normal resume operation operation and shuts off 5 seconds after the message is displayed 2 4 Atria Electrocardiograph Operating Instructions 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 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
58. e opposite is also true Perth Australia is 8 in Windows and is 8 for the Atria Decrease the time zone value by one hour on the Atria during Daylight Saving Time or Summer Time period Refer to Time on pg 4 18 to change the current time setting During this period the displayed current time in Atria and the network will match but the time zone values will be different 802 11 AND ETHERNET 802 11 CONNECTION SETUP The Atria uses an 802 11g USB adapter for either a 802 11b or 802 11g networks The Atria automatically scans all channels to find the correct channel used by the access point at a given location Use the Ethernet 802 11 selection to set up both an Ethernet and a 802 11 connection The system will send the data over a wireless network if a connection is available If a wireless connection is not available connect a network cable to send the record 1 Select Network Type gt 802 11 gt Use DHCP or Network Type gt Ethernet 802 11 gt Use DHCP Recommended Select ON for dynamic IP address assignment Select OFF for fixed IP address assignment 2 Select a setting for Wireless Security None Turn off Wireless security WEP Wired Equivalent Privacy When Wireless Security is WEP Select the setting for Wireless Authentication open shared WPA or WPA2 Personal Wi Fi Protected Access Supplicant Config custom configuration WPA or WPA2 Enterprise Wi Fi Protected Access 5 A Atria Elec
59. elected lead configuration Description Figure above shows default Press keys 1 through 6 for alternate configurations D Sensor status Indicates signal quality If signal quality is bad the display indicates the problem Fail Drift or Noise and shows which sensor is affected E Settings Information Displays user settings Press the key indicated to change 9 Stable 40 Hz or 150 Hz 7 25 mm s 50 mm s 12 5 mm s 8 10 mm mV 20 mm mV L 10 C 5 L 20 C 10 5 mm mV Alt 1 User 1 settings Alt 2 User 2 settings F Power Status Indicates power source and status AC the Atria is connected to external power Low low battery Bat the Atria is powered by the battery Atria 6100 Menu Screens Use the Menu keys to go to one of the main menus Patient Enter patient demographics Directory Display the patient directory Setup Change system settings Send Rec Communications options NOTE Press ALT H to access the Help menu Each menu or list item has an associated hot key The hot key is indicated by the letter underlined on the list item For example the list item Years may be selected by pressing Y Some List fields have default settings For example the default setting for Age Format is Years The example below shows how to navigate a menu screen to enter patient demographics 3 8 Atria Electrocar
60. ellaneous 4 13 Setup 5 12 Setup Patient menu 4 11 Setup Printer menu 5 8 setup report 9 3 Setup Send Receive menu 5 3 somatic tremor 10 5 specifications 11 14 speed change current 7 5 default setting 4 7 STABLE Baseline filter 4 8 standards 11 15 standby mode 2 3 Stat ECG acquire 7 1 status send 8 8 unprinted and demographics records 8 5 Summer Time period See Daylight Saving Time supplicant configuration 5 6 symbols vi system settings 4 13 T tachycardia limit 4 6 technical specifications 11 14 testing equipment 11 3 time setting 4 13 tips ECG 7 4 trace problems 10 2 troubleshooting 10 1 U units of measure settings 4 13 upper frequency response 4 7 user field settings 4 12 user select 4 13 V V3 placement 4 12 7 9 W wait for good data 4 5 warnings v warranty 11 15 waveform amplitude 4 7 waveform settings change current 7 5 web services retrieving ECG records 8 11 retrieving orders 8 10 Welsh bulbs 6 7 workflow paperless 1 4 Atria Electrocardiograph Operating Instructions 3 4 Atria Electrocardiograph Operating Instructions FCC CONNECTION INFORMATION The Atria internal socket modem complies with Part 68 of the FCC Rules On the side of this equipment is a label that contains among other information the FCC Registration Number and ringer equivalence number REN for this equipment If requested
61. em is solved This equipment may not be used on coin service provided by the telephone company Connection to Party Line Service is subject to state tariffs Contact the state public utility commission public service commission or corporation commission for information This device is equipped with a USOC RJ11C connector EQUIPMENT ATTACHMENT LIMITATIONS NOTICE The Atria internal socket modem has been certified by the Canadian Department of Communications This certification means that the equipment meets certain telecommunications network protective operational and safety requirements The Department does not guarantee the equipment will operate to the user s satisfaction Before installing this equipment user s should ensure that it is permissible to be connected to the facilities of the local telecommunications company The equipment must also be installed using an acceptable method of connection In some cases the company s inside wiring associated with a single line individual service may be extended by means of a certified connector assembly telephone extension cord The customer should be aware that compliance with the above conditions may not prevent degradation of service in some situations Repairs to certified equipment should be made by an authorized Canadian maintenance facility designated by the supplier Any repairs or alterations made by the user to this equipment or equipment malfunctions may give the telecommunic
62. ent place his her hands under the buttocks Atria Electrocardiograph Operating Instructions 10 5 10 Troubleshooting Baseline wander Normally the baseline will stabilize within a few seconds The following conditions may also cause an baseline wander Patient breathing Dried out or peeling off electrodes Improperly prepared skin Improperly applied electrodes with poor skin contact Dirty electrodes Body motion Fix the faulty electrode or turn on the Stable Filter to correct Figure 10 2 Poorly Affixed Sensor Artifact Electrical Interference Electrical interference may produce a wide baseline Its amplitude depends on the strength of the current source and the lead being recorded In any one lead the amplitude of the interfering signal is uniform Figure 10 3 Electrical Interference Artifact ara i 10 6 Atria Electrocardiograph Operating Instructions Recognizing and Reducing ECG Artifacts To reduce electrical interference Keep the power cord away from the patient and patient cable Connect the Atria to a properl
63. eport Format Rhythm Lead Channel 2 This selection displays for the following formats only 3 3 format Rhythm leads display at the bottom of the printout LEAD LEAD Il LEAD Ill aVR aVL aVF V1 V2 V3 V4 V5 V6 aVR Rhythm Lead Channel 3 This selection displays for the following formats only 3 3 format Rhythm leads display at the bottom of the printout LEAD LEAD Il LEAD Ill aVR aVL aVF V1 V2 V3 V4 V5 V6 aVR Print Rhythm Page Enable a separate 10 second rhythm report as part of the ECG report The rhythm page prints 10 seconds of all 12 leads 12 Leads at 25 mm s 12 Leads at 50 mm s OFF Print Median For interpretive units only ON Complex Page Enable the Median Complex printout as part of the ECG OFF report Number of Enter the number of report copies to print in addition to the text entry Copies automatic printout Valid entries are 0 through 5 4 4 Atria Electrocardiograph Operating Instructions ECG Settings Sequence Configure automatic functions ECG Menu Items Description Selections Sequence Wait for good When enabled ON the system delays the ECG reports ON data until the system has collected ten seconds of low noise OFF waveform data all electrodes must be connected To force an immediate report press ECG again when the system displays Waiting for Good Data The report includes Warning Data quality may af
64. ertificate file into the USB port on the back of the Atria Press Home and then press Setup Select Service Functions from the Setup menu The Atria displays a warning message Press Enter 7 Use the navigation keys to select Copy wpa supplicant cert from usb and then press Enter The system copies the file and displays a message indicating the trans fer was successful Press On Stby twice to reboot the Atria Atria Electrocardiograph Operating Instructions 5 7 5 Communications Setup CONFIGURE THE ATRIA TO USE THE SUPPLICANT CONFIGURATION 1 Press Home and then press Setup 2 Select Send Receive gt Setup Network Connection from the Setup menu 3 Select the following options a Network Type select 802 11 b Use DHCP select ON or OFF c Wireless Security select Supplicant Config 4 Tocomplete the setup configure Email see Setup Email on pg 5 10 and EMR Communications Setup EMR Communications on pg 5 12 External Printer Setup WARNING A Shock hazard Plain paper printers must be compliant with IEC 60950 External printing requires network setup See Network Setup on pg 5 3 Atria Printer Configuration Plain paper printing is available for all printing except Manual and Auto Rhythm printouts 1 Press Home and then press Setup 2 Select Printer gt Plain Paper Printing and either Local USB or BlueTooth Network Ethernet or 802 11 Off No prin
65. fect computer interpretation When disabled OFF the ECG report starts after 10 seconds of ECG waveform data regardless of quality No warning message is included NOTE The ECG report does not include waveform data for disconnected electrodes Leads with disconnected electrodes are not used in the ECG analysis Auto Print Sets ECG report print options for thermal plain paper or ON both Prompt e ON automatically print OFF Prompt prompt before printing OFF automatically bypass printing Auto Save Sets ECG reports save options ON e ON automatically save Prompt Prompt prompt before saving Auto Send Requires the Communications option ON See Communications Setup on pg 5 1 and Setup EMR Prompt Communications on pg 5 12 OFF e ON automatically send Prompt prompt before sending OFF do not automatically send Auto Email Requires the Communications option Also requires an ON SMTP server address and an email address Prompt See Communications Setup on pg 5 1 and Setup OFF Email on pg 5 10 NOTE By default automatic email uses the first email address e ON automatically email Prompt prompt before sending email OFF do not automatically send email Atria Electrocardiograph Operating Instructions 4 5 4 User Settings Interpretation Preferences Settings below are available only on interpretive units
66. gs current 7 5 cleaning 11 1 communication options setup 5 1 communication setup 802 11 5 4 certificates 5 6 Ethernet 5 3 5 4 PPP 5 6 supplicant configuration 5 6 configuration options 4 1 conforms to standards 11 15 connect patient cable 2 3 6 8 contact information 1 1 contrast setting 4 14 copies print 8 2 custom leads configure 4 9 select 3 3 customer service phone numbers 1 1 D data quality filter 4 5 date format 4 13 Daylight Saving Time 4 13 5 4 delete patient record 8 4 delete records all 8 6 directory add patient 8 4 automatic deletion 8 6 delete all records 8 6 password protection 4 14 settings 4 12 status 8 5 directory full message 8 6 directory report sample report 9 2 disclaimer service 11 7 disclosures 11 7 disinfecting 11 1 disposable sensors 6 5 ECG acquire 7 1 acquire new using existing patient 8 2 print copy 8 2 print new 8 4 8 5 sample 3 channel rhythm 9 7 sample 4 channel 9 5 sample 6 channel 9 6 troubleshoot artifacts 10 5 ECG reports 7 3 ECG tips 7 4 Edit Patient display 3 8 3 11 electrical apparatus multiple 1 3 electrolyte 6 6 e mail options 4 5 setup 5 10 EMR system retrieving ECG records 8 11 retrieving orders 8 10 sending records 8 7 environmental specifications 11 15 equipment test 11 3 type 11 15 equipotential grounding 2 2 Ethernet connection 5 3 5 4 F facility name setting 4 13 facto
67. hen continue with Send All New or Selected ECGs SEND ALL NEW OR SELECTED ECGS 1 Press Send Rec 2 Press Select Atria displays the status of the transmissions Atria Electrocardiograph Operating Instructions 8 7 8 Patient Records SELECT RECORDS TO SEND This menu allows you to review each record for send status For each record you may select to send or place the record on hold The send status defaults to send You may change the send status for a record at any time 1 Press Send Rec 2 Select Select Records to Send 3 Review send status 4 Tochange send status a Select the record to change status b Select Hold or Send and press Select Fax a Patient Record WARNING Misdiagnosis ECG reports images viewed or printed in pdf format at a size other than 100 may be appear distorted Also records sent by fax may not be suitable for diagnostic use due to the low resolution of some fax receiving equipment Patient records can only be faxed if the fax option is enabled and properly set up Refer to the beginning of Chapter 5 for general communications setup and Setup Fax on pg 5 10 1 Press Home 2 Press Patient 3 Select View Patient Directory 4 Scroll down and select the desired patient The ECG Review menu displays Select Fax ECG Select the desired fax destination e 8 8 Atria Electrocardiograph Operating Instructions Communications Options Ema
68. heoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Atria is used exceeds the applicable RF compliance level above then the Atria should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Atria gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Amplitude modulated at 80 with a modulation frequency of 10 KHz per EN 60601 2 25 11 12 Atria Electrocardiograph Operating Instructions EMC Declaration Tables Recommended Separation Distances Refer to the following table for recommended separation distances between the Atria and portable and mobile RF communications equipment The Atria is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the Atria can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Atria as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter Separation distance according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz
69. his chapter are from the Atria 6100 They are identical to the reports for the Atria 3100 Atria Electrocardiograph Operating Instructions 9 1 Prints a list of all patient records stored in the directory Print Directory Report 9 Sample Printouts VU LEGU Y LZ 3 HH ON Aang dd 923 0 SOILLIEO 79166 Jeu e9 6 01 dd 993 11 6 90 41120 9CC6LEE 71 6 903 11 6 90 4110 S9vb6zi ousoy 8 Jd 993 21 6 9OILLIED 16011090 1015 Auey 994 21 6 90 4110 16011 090 1015 Auey seuon 9 903 21 6 90 ZLIE0 002160112090 1915 Ped JY S ug ysowsa 65 91 ui 4013 p ug 68 9200 t 8211 uosue M ug ueowad LL8bbL6 uosuepusH ug uooWad tELISL6 ueAug uos IM snjeis aeq wooy al auew 30 21 60 9002 ZL1E0 AuOJOBUIG jus jBd 9 2 Atria Electrocardiograph Operating Instructions Setup Report Setup Report The Setup Report is a list of all current settings The sam
70. his field displays as No No ld and pressing ECG results in STAT ECG heart rate B Sensor status or Indicates signal quality or heart rate If sensors are not ok the display indicates the problem Fail Drift or Noise and shows which sensor is affected If sensors are ok then heart rate is indicated here C Suggested next step Directs the user to the next logical step D Power Status Indicates power source and status AC unit is connected to external power Low low battery Bat unit is powered by the battery 3 10 Atria Electrocardiograph Operating Instructions Display Atria 3100 Figure 3 6 Atria 3100 Patient Source Selection Menu Atria 3100 Menu Screens Use the Menu keys to go to one of the main menus Patient Enter patient demographics Directory Display the patient directory Setup Change system settings Send Rec Communications options NOTE Press ALT H to access the Help menu Some List fields have default settings For example the default setting for Age Format is Years The example below shows how to navigate a menu screen to enter patient demographics Patient Source Selection Enter New Patient Label Text Description A Menu Title Displays the menu title of the current menu or the menu selection B Menu Items Displays the sub menu or the entry field for the menu selection C C
71. hm to print a manual rhythm strip Press 0 to place a 1 mV simulated calibration pulse on the printout To stop printing Press Stop to cancel printing at any time Press ECG to interrupt printing and begin another report Acquiring an ECG Using Alternative Lead Placements The Alternate Chest Lead ECG allows acquisition of right chest leads and expanded left chest leads The standard ECG is an important part of the Alternate Chest Lead ECG If acquiring an Alternate Chest Lead ECG run a standard resting ECG before continuing for more information see Acquiring a Stat ECG on pg 7 1 Configure either CUSTOM LEAD 1 or CUSTOM LEAD 2 for the desired lead placement see Custom Lead Settings on pg 4 9 1 2 Prepare the patient See Patient Preparation on pg 6 2 Attach electrodes according to the specific instructions for each lead configuration see Alternative Lead Placements on pg 6 8 Press the 5 or 6 key to select the custom lead format NOTE alternate chest lead is selected then Alternate Chest Electrodes displays on the Home screen The message Alternate Chest Lead ECG or RIGHT CHEST LEAD ECG prints in place of the interpretation Additionally Atria uses the alternate chest lead format for standard and rhythm printouts until another custom lead format is selected Verify the patient s heart rate displays on the Home screen If the Atria does not display the heart rate
72. horizontal level with Vg Cg and V7 C7 at mid scapular line horizontal level with V7 C7 and Vg Cg next to spinal column horizontal level with VgR CgR at posterior axillary line horizontal level with VgR CgR and V7R C7R at mid scapular line horizontal level with V7R C7R and VgR CgR next to spinal column e WR Atria Electrocardiograph Operating Instructions 6 9 6 Patient Preparation 6 10 Atria Electrocardiograph Operating Instructions Chapter 7 Acquiring ECG Reports Acquiring a Stat ECG The Atria does not require patient demographic information for an immediate ECG Enter patient demographic information at any time See ECG Tips on pg 7 4 If no patient ID is entered the Atria prints STAT date time in the Patient ID field To acquire a stat ECG 1 Prepare the patient for the recording See Patient Preparation on pg 6 1 2 Press On Stby if necessary Verify the patient s heart rate displays on the Home screen If the Atria does not display the heart rate check the problem leads listed on the display Replace faulty electrodes if necessary 4 Press ECG twice to acquire a stat ECG report NOTE Pressing ECG twice overrides the Wait for Good Data message and may result in a flat line ECG because the Atria hasn t acquired enough good data Recommended Workflow AN If possible enter patient demographic information before performing tests Patie
73. il a Patient Record WARNING Misdiagnosis ECG reports images viewed or printed in pdf format at a size other than 100 may be appear distorted Also records sent by fax may not be suitable for diagnostic use due to the low resolution of some fax receiving equipment Patient records can only be emailed if the email option is enabled and properly set up Refer to the beginning of Chapter 5 for general communications setup and Setup Email on pg 5 10 1 Press Home 2 Press Patient 3 Select View Patient Directory 4 Scroll down and select the desired patient The ECG Review menu displays Select Email ECG 6 Select the desired email destination Retrieving ECG Records and Orders from an EMR System with Web Services NOTE Using the record retrieval feature requires communications option See Communications Setup on pg 5 1 Use the record retrieval feature to receive ECG record or orders from the EMR system based on the EMR connection setting see Set up Web Services on pg 5 12 Follow the instructions below to retrieve records from an EMR system such as Heartcentrix or the Pyramis ECG Database Management system version 6 1 or later or other compatible data management system If the EMR system supports order entry then the Atria can retrieve orders from this system Atria Electrocardiograph Operating Instructions 8 9 8 Patient Records RETRIEVING ORDERS 1 Press H
74. ilter is always off Print Measurement Matrix To review the numerical data for a record The measurement matrix contains numerical data such as P wave duration derived from the median complex for the record NOTE This report is available on an interpretive Atria only For detailed information on this report see Measurement Matrix on pg 12 1 Print Rhythm Report Prints a rhythm report 12 leads all 10 seconds of the ECG data Show Status Shows the date and time of the record and record status The status of a record is important especially when transmitting to an EMR system Record status determines which records are retained if the directory becomes full see Automatic deletion when the Directory is full on pg 8 6 The table below details record status codes Code Record Status Detail Demogr Demographics Only The record contains only patient demographic information The record does not contain an ECG report Order Downloaded Order The record is downloaded unfilled demographics only order from the EMR System ECG 12 Lead The record contains a 12 lead ECG RtE Alternate Chest Lead The record contains an Alternate Chest Lead non standard ECG Pr Printed The ECG record has been printed by the Atria electrocardiograph St Sent The record has been sent to an EMR system or a network location Rv Received The record is an ECG downloaded from the EMR System
75. ions see Loading Recording Paper on pg 2 5 or press ALT H to access the Help menu and then select Loading Paper Saving Reports The Atria automatically saves ECGs If the Atria 1s set up for network access the ECG can also be automatically sent or emailed For more information see Sequence on pg 4 5 NOTE disable automatic saving of ECG reports see Auto Save on pg 4 5 After the ECG has been saved the Patient Review menu is displayed See How to Display a Patient Record on pg 8 2 ECG Tips Patient Data and Interpretation Enter all patient information Some patient information directly affects ECG analysis The physician uses this information when interpreting ECG reports Also an interpretive Atria provides more accurate and complete analysis statements when patient information is complete Enter patient information at any time either before or after the ECG Changing age gender race medication or clinical classification after acquisition causes the interpretive Atria to prompt to reanalyze the data Any changes in interpretation are included in future printouts If the data is not reanalyzed edits are not saved 7 4 Atria Electrocardiograph Operating Instructions Change Recorder Speed Gain Frequency Response Acquiring a Clean Trace To obtain a clean trace with very little noise ensure Wait for Good Data is set to ON in the ECG menu If there is a problem during a recording
76. layed press Select Press Manual Rhythm When printing starts press Stop Again press Manual Rhythm When printing starts press Stop Report is printing STAT in the Patient ID No patient last name and ID number field of the report was entered for the patient 10 4 Atria Electrocardiograph Operating Instructions Recognizing and Reducing ECG Artifacts Recognizing and Reducing ECG Artifacts Figure 10 1 Somatic Tremor and Patient Movement Artifact OVERLOAD message Defibrillating the patient will interfere with the Atria sensors and may result in loss of the trace or erratic trace deflections The OVERLOAD message indicates the waveforms may not be accurate An overload condition may also be caused by Dried out electrodes Improperly prepared skin Improperly applied electrodes with poor skin contact Dirty electrodes The condition must be corrected before the overload condition clears Rapid large and erratic deflections A broken wire in the patient lead or a poorly applied sensor may cause rapid large and erratic trace deflections Motion artifact Patient movement and muscle tremor may result in abnormal traces To minimize this artifact toggle the artifact filter to 40 Hz using the 9 key In addition try to gain the patient s cooperation in staying very relaxed and still Sometimes somatic tremor is unavoidable but its effects may be minimized by having the pati
77. lter to 150 Hz for more information see How to Display a Patient Record on pg 8 2 Additionally you may change the default settings on your Atria to acquire new ECGs using the 150 Hz filter refer to Artifact Filter on pg 4 7 Pacemaker Detection and Suspension Unlike ECG signals pacer signals are sharp and narrow impulses External interference spikes sometimes mimic the shape of pacer impulses Although this is a rare occurrence it can obstruct accurate pacer detection When interference occurs it causes an over detection of possible pacer events and could result in interpretation errors Pacer detection suspension is designed to prevent possible interpretation errors due to interference for pacing patients However the detection suspension will not affect interpretation reports for patients who do not carry pacemakers NOTE If spikes appear while pacer detection is suspended refer to Chapter 10 for information on eliminating electrical interference Once you have eliminated the source of the interference proceed with ECG acquisition Atria Electrocardiograph Operating Instructions 11 9 11 Maintenance and Service EMC Declaration Tables WARNING Electromagnetic interference Position the Atria away from other electrical or electronic equipment if possible The presence of strong EMI fields or generated by RF noise on the line power or by electronic surgical or noise or input overload conditions
78. manual rhythm report a continuous rhythm strip of the leads currently selected This report runs until the Stop key is pressed ECG Settings Number Keys 1 2 3 or 4 To select pre programmed lead triplets The leads are printed on manual rhythm and auto rhythm reports 5 or 6 Custom lead 1 or Custom lead 2 to select user defined leads The leads are printed on manual rhythm and auto rhythm reports See Custom Lead Settings on pg 4 9 for setup information 7 Select paper speed 12 5 25 or 50 mm sec 8 Select ECG gain 5 mm mV 10 mm mV 20 mm mV L10 C5 mm mV L20 C10 mm mV 9 Toggles the upper ECG filter frequency response 40 or 150 Hz 0 For a 1 mV calibration pulse on auto or manual rhythm printouts Atria Electrocardiograph Operating Instructions 8 8 3 User Interface Function Key Description Navigation Back Return to the previous menu or display Select Accept or edit the current selection Previous Next Scroll up or down Left Right Atria 6100 Move cursor to left or right Home Go to the Home or main display Status Sensor Atria 3100 Display Sensor status Menu Patient Select a patient current new or saved Directory Access stored patient records Send Rec Communication options Setup Configure settings Help Help menu Main Keyboard A through Z
79. ment compatibility Network Setup The following communication options require network setup Email Printing to network printers Sending to EMR via network connection Sending to shared location on network NOTE Press ALT H to access the Help menu Select Network Setup for additional information Atria Network Configuration The facility network must be set up before connecting the Atria to the network Use these instructions to configure Ethernet and 802 11 networks 1 Press Home and then press Setup 2 Select Send Receive gt Setup Network Connection ETHERNET CONNECTION SETUP To set up the network using an RJ 45 Ethernet connection 1 Select Network Type gt Ethernet gt Use DHCP Recommended Select ON for dynamic IP address assignment Select OFF for fixed IP address assignment 2 Enter the following a When DHCP is OFF enter IP address IP Address for the Atria typically assigned by the network administrator Subnet Mask typically 255 255 255 0 Gateway IP address for the Gateway Atria Electrocardiograph Operating Instructions 5 8 5 Communications Setup b UTC GMT Time Zone Offset The default is 6 for Central Standard Time For other time zones use the Time Zone listed on your computer NOTE The Windows UTC GMT Time Zone Offsets are the inverse of the Atria For example Windows Central Standard Time is 6 but the Atria notates Central Standard Time as 6 Th
80. n the range of 30 to 250 bpm with a tolerance of 10 or 5 bpm whichever is greater Question marks appear on the printout if the heart rate is out of the specified range WARNING Patient injury or death Do not use the Atria for unattended or continuous A patient monitoring The Atria has no audible or visible alarms and change to patient condition may not be immediately known The Atria is only intended for short term ECG waveform acquisition 11 8 Atria Electrocardiograph Operating Instructions Performance Disclosures 40 Hz Artifact Filter WARNING Misdiagnosis Using an artifact filter may affect the ECG output the physician is responsible for taking this into account when reviewing and interpreting the ECG The primary purpose of the 40 Hz artifact filter is to remove skeletal muscle artifacts i e undesired signals The filter provides a better signal quality when high frequency noise appears However the filter could also lower the peak of the QRS complex as well as smooth some subtle details of ECG signals For example this may occur with left ventricular hypertrophy and with pediatric signals The physician should take into account the effect of the artifact filter when reviewing such cases The 40 Hz artifact filter does not affect the automatic 12 lead measurement and interpretation analysis but may affect the printed waveform To view the full bandwidth signal for an ECG change the artifact fi
81. nabled Enter New Patient Creates one or more patient files before recording ECGs For more information see Enter Patient Demographics on pg 7 2 Print All New ECGs Print all ECGs in the directory not yet printed their Record Status is not Pr Print Entire Directory Prints all records in the directory Print Open Orders Prints only demographic only records no attached ECG Print Pending Records Prints only records that have not completed their lifecycle on the device Show Directory Status Shows all demographics only unprinted or unsent records NOTE If Show Directory Status is not listed in the directory then the directory does not contain demographics only unprinted or unsent records Atria Electrocardiograph Operating Instructions 8 1 8 Patient Records AN Delete All Records Permanently deletes all records Caution Data loss Deleting a patient record permanently removes the record Once deleted a record can not be recovered How to Display a Patient Record 1 Press Home and then press Directory 2 Select View Patient Directory and then select a patient The ECG Review menu displays NOTE The system also automatically displays the ECG Review menu after taking an ECG NOTE Additional communications menu items may be displayed depending on the options available and set up See Communications Setup on pg 5 1 3 Press Select to select the displayed opti
82. 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 gt gt 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 1 will not become energized under single fault conditions As a result it 1s safer not to connect the exposed metal to the internal chassis or the functional earth of the Atria This method of protection 1s 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
83. nd Service Immunity IEC 60601 Compliance Electromagnetic environment test test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the Atria including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 IEC 61000 4 6 150 kHz to 80 d 1 2VP MHz Radiated RF 3 Vime d 1 2VP 80 MHz to 800 MHz IEC 61000 4 3 3 V m to 2 5 d 2 3VP 800 MHz to 2 5 GHz 2 where is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800MHZz 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 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted t
84. nd disclosure 11 9 enhancement setting 4 8 paper speed change current 3 3 default 4 7 paper loading 2 5 paperless workflow 1 4 password protection 1 3 4 1 4 13 4 14 patient cable cleaning 11 1 connecting 2 3 6 8 testing 11 3 patient demographics configuring 4 11 entering 7 7 patient records 8 1 Patient Review display 8 2 pediatric acquire ECG 7 3 lead placement 6 8 performance disclosures 11 7 phone numbers 1 1 power 2 2 2 3 cord connect 2 2 2 3 indicator 2 2 2 4 medical grade 2 2 2 3 on and off 2 3 standby mode 2 3 status 3 8 3 10 PPP communication 5 6 preparation 2 Atria Electrocardiograph Operating Instructions patient 6 1 print new ECG 8 4 8 5 print options 4 5 print settings plain paper printer 5 8 printed reports 7 3 printer problems 7 4 10 4 printhead clean 11 2 printouts samples 9 1 Q QTc formula 4 6 R record delete 8 4 print copy 8 2 record status 8 3 records automatic deletion 8 6 delete all 8 6 records saved 8 1 reusable sensors 6 6 cleaning 11 1 rhythm acquire printouts 7 6 configure 4 9 sample 3 channel report 9 7 S safety features 2 1 specifications 11 15 sample printouts 9 1 save options 4 5 saving ECG records 7 4 send EMR or network share 8 7 options 4 5 status 8 8 sensors disposable 6 5 reusable 6 6 separation distances recommended 11 13 serial cable connect 5 2 settings misc
85. ng Instructions 1 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 Chapter 12 Patient 6 1 oot ase Se 6 1 Patient Preparation 6 2 Skin Preparation Sos rs not fone pose des noirs hes 6 2 Sensor Application 6 3 Resting ECG Lead Placement amp 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 Acquiring ECG Reports 7 1 Acquiring a Stat ECG co soa cupo a no te Soe UL bs 7 1 Recommended Workflow 7 1 Acquiring an ECG Using Pediatric Lead Placements 7 3 ECG Reports bee Geek pO awe IP e REGE 7 3 Tips ie Lehane dete tes eet 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 Patient
86. nicate to an EMR system The Atria can send ECG records to the EMR system The Atria can retrieve previous ECG records from the EMR system Ifthe EMR system supports order entry the Atria can retrieve orders from the EMR system For more information see Sending ECG Records to an EMR System on pg 8 7 and Retrieving ECG Records and Orders from an EMR System with Web Services on pg 8 9 NOTE To connect to the web via a network configure this device for the network Refer to the appropriate section in Network Setup for wired ethernet 802 11 wireless or PPP network setup CONFIGURE WEB SERVICE 1 Press Home and then press Setup 2 Select Send Receive Setup EMR Connection 3 Select EMR Connection gt Web Services 4 Select EMR Description and enter the name of the server or a text description of the EMR the Atria will connect to 5 Select Web Services URL IP and enter the URL components as follows a Fora secure server enter https otherwise enter http b Enter the IP address of the server followed by a slash c Enter the pathname followed by a slash d Enter the server application name For example https 198 24 137 22 heartcentrixapi userwebapi asmx 6 Enter the Web Services Provider ID For more information see your EMR administrator 5 12 Atria Electrocardiograph Operating Instructions Setup EMR Communications 1 Enter the Institution Number The Instituti
87. not display view problem leads on the display Replace faulty electrodes as necessary 4 Enter patient demographics NOTE acquire a stat ECG press ECG and then press Select or ECG to select Acquire STAT ECG for a new patient Press ECG Use the navigation buttons to display Acquire ECG current patient data then press Select ECG Reports The Atria automatically includes a formatted 12 lead report with demographics in any ECG printout Additionally an Atria with the optional interpretation feature automatically prints the interpretive analysis on the report this feature can be disabled The Atria can also automatically print the following pages with the ECG Rhythm page Copies of ECG with or without analysis Median complex report interpretive Atria only For more information on enabling these reports or to disable automatic printing see Report Format on pg 4 2 Atria Electrocardiograph Operating Instructions 17 3 7 Acquiring ECG Reports AN Plain Paper Printing The Atria can be configured to print ECGs to a plain paper printer Caution Data loss Always check plain paper printouts before disconnecting the patient and ending the procedure Printing Problems Thermal Printer If the Atria runs out of paper or if the paper jams while printing an ECG either reload the paper and continue printing or press Stop to save the record without printing For paper loading instruct
88. nt demographic information also may be entered after acquisition WARNING Misdiagnosis Some patient information directly affects ECG analysis Your patient s physician uses this information when interpreting ECG reports Likewise an interpretive Atria provides more accurate and complete analysis statements when you enter complete patient information Prepare the Patient Prepare the patient for the recording see Chapter 6 Patient Preparation Atria Electrocardiograph Operating Instructions 7 1 7 Acquiring ECG Reports Enter Patient Demographics Once patient demographics are entered it is not necessary to immediately acquire an ECG The Atria allows multiple patients to be entered at the same time When acquiring an ECG for a particular patient select the appropriate patient from the patient directory 1 Press On Stby if necessary 2 Perform one of the following Press Patient select Enter New Patient and enter the new information as prompted Press Directory select Enter New Patient the new information as prompted Press Directory select View Patient Directory and select an existing patient Edit the existing information as necessary NOTE For a complete description of the patient demographic fields see Patient Demographics on pg 7 7 Acquire ECG NOTE Press Stop at any time to halt an ECG Press Home 2 Verify the patient s heart rate displays on the Home screen If the Atri
89. ntents in the directory Caution Data loss Deleting a patient record permanently removes the record Once deleted a record can not be recovered Press Directory Press Next to scroll to Delete All Records Press Select Loss of Data Continuing with the following steps will permanently erase all saved records To cancel the request and return to the Direc tory menu press Select Press Next Press Select Press Next Press Select pop ope dg m Automatic deletion when the Directory is full If you create a new record when the directory is full the Atria deletes an older record to make room for the new record There are rules based on record status which determine which records are automatically deleted The oldest record with the proper status is deleted Atria without communication options Ifthe Atria is not configured for communication with an EMR system then any record with status Pr may be deleted Records with status Demogr demographics only records are never deleted Records without status Pr unprinted records are never deleted Atria with communication options Ifthe Atria is configured for communication with an EMR system then a record with status St may be deleted Records with status Demogr or Order demographics only records are never deleted Records without status St unsent records are never deleted Records with status Hold are never deleted
90. ntities of fluid immediately discontinue use and contact a qualified service technician Caution A Equipment damage Do not hot sterilize Atria cables or sensors ATRIA EXTERIOR To Clean and Disinfect Use a clean damp cloth to apply a disinfectant listed above PATIENT CABLE AND REUSABLE SENSORS To Clean and Disinfect Use a clean damp cloth to apply a disinfectant listed above Atria Electrocardiograph Operating Instructions 11 1 11 Maintenance and Service PRINTHEAD Caution Equipment Damage Abrasive cleaners or harsh chemicals may damage N the printhead If cleaning is required use a lint free swab dampened with isopropyl alcohol Check the printout to ensure the printing 1s legible and dark Light printing particularly at the baseline may indicate a dirty printhead Inspect for Damage WARNING Hazardous voltage The interior of the Atria may retain hazardous voltages even after the Atria is shut off and the power cord disconnected There are no internal user serviceable parts other than the battery Do not remove any other cover or try to disassemble the Atria If the Atria appears damaged immediately discontinue use and contact a qualified service technician WARNING Misdiagnosis Operating a damaged Atria or using worn or damaged 1 cables or connectors may cause incorrect or unreliable readings If the Atria appears damaged immediately discontinue use and contact a qualified service techni
91. 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 150p 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 p
92. ome 2 Press Send Rec 3 Select Get Patient Orders 4 Specify the criteria for the orders NOTE Entries are not case sensitive a To receive all current orders leave all fields blank To receive orders for a given department only select the appropriate department receive a specific order enter the order number in Order d To receive orders for a specific patient enter the patient ID MRN in ID 5 Press Send Rec After a few seconds the Atria displays a list of all orders that meet the criteria specified above 6 Select the orders a select all records hold down and then press 1 b To de select all records hold down Alt and then press 2 c Toselect or de select individual records highlight the record and press Select Selected records display with a brace Atria 3100 or a checkmark Atria 6100 in front of the record 7 Press Send Rec After a few seconds the Atria begins downloading the records and indi cates the progress of the download NOTE If the system has previously downloaded orders that are not yet filled and these orders become obsolete then the old orders are automatically removed from the system during this procedure Obsolete orders are orders which have been cancelled or orders that have already been fill by another electrocardiograph 8 10 Atria Electrocardiograph Operating Instructions Communications Options RETRIEVING ECG REC
93. on Acquire New ECG on Same Patient The Atria acquires a new ECG using the current patient s demographics Print copy of this ECG Prints a copy of the saved ECG NOTE Ifthe directory contains additional unprinted ECGs a prompt is displayed to print all unprinted ECGs or only the current ECG Print Plain Paper ECG Only available if a external printer has previously been configured Edit Demographics Update patient demographics For more information on patient demographic fields see Patient Demographics on pg 7 7 NOTE Ifyou edit age gender race medication or clinical classification after acquisition an interpretive Atria provides the option to reanalyze the data Any changes in interpretation are included in future printouts If you do not reanalyze the data edits are not saved Change Speed Gain or Filter Change printer speed signal gain or filter settings Print settings for saved records can be changed once the record is reprinted changes affect the selected record only NOTE These settings can be changed at the Home screen using the 7 8 or 9 keys before ECG acquisition 8 2 Atria Electrocardiograph Operating Instructions How to Display a Patient Record Print Median Complex Report To review the averaged beats for a record on an interpretive Atria the median complex is used as the basis for all computerized analyses NOTE Chart speed is fixed at 50 mm s and the artifact f
94. on number is transmitted to the EMR system with the ECG record Enter 1 unless the server services multiple institutions Enter a Device ID The Device ID 1s transmitted to the EMR system with the ECG record Enter a unique number to identify this specific ECG device REGISTER THE ATRIA WITH THE WEB SERVER 1 2 3 Press Home and then press Setup Select Send Receive gt Register Device with Web Services Enter the Web Services Provider ID For more information see your EMR administrator Enter the Web User ID Enter the Web Password Verify the Atria is connected to the network with either a 802 11 or an ethernet cable Press Send Rec After a few seconds the Atria displays a list of one or more institutions Select the institution that matches the Institution ID entered in step 7 Configure Web Service on pg 5 12 Press Send Rec to send the registration NOTE Ifthe Atria reports errors the communications log contains more information regarding the errors To print the communications log Press Setup and then select Print Communications Log For more information press ALT H to access the Help menu and select Troubleshooting gt Communications DOWNLOAD THE EMR SUPPLIED CUSTOM HEADER NOTE The Atria must be registered before performing this procedure see Register the Atria with the Web Server on pg 5 13 Press Home and then press Send Rec Select Get Custom Header Af
95. one Offset Atria Electrocardiograph Operating Instructions 5 5 5 Communications Setup PPP SETUP Use the PPP setting to connect the Atria to a PPP Server 1 Select Network Type gt Ethernet gt Use DHCP Recommended Select ON for dynamic IP address assignment Select OFF for fixed IP address assignment 2 Enter the following a When DHCP is OFF enter IP address IP Address for the Atria typically assigned by the network administrator Subnet Mask typically 255 255 255 0 Gateway IP address for the Gateway b PPP Phone Number phone number of the PPP Server c PPP Phone Type select TOUCH TONE or Pulse d PPP User user name set up on the PPP server e PPP Password the password set up for the PPP user UTC GMT Time Zone Offset The default is 6 for Central Standard Time imr For other time zones use the Time Zone listed on your computer See the Time Zone instructions and note on 5 4 for configuring the UTC GMT Time Zone Offset Security Settings Supplicant Configuration Use the Supplicant Configuration setting to configure the Atria with a custom configuration when the standard security options are not compatible with your wireless network Use the Supplicant Configuration option if your wireless network requires the use of digital certificates To configure a supplicant configuration complete the following steps Create a supplicant configuration file Install the configur
96. onform to body contours and no strain is placed on the sensors Atria Electrocardiograph Operating Instructions 6 5 6 Patient Preparation Reusable ECG Sensors Caution N Baseline drift Never mix patient electrode types or brands Dissimilar metals or other incompatibilities may cause considerable baseline drift and may increase trace recovery time after defibrillation Electrolyte NOTE Watches or jewelry may be damaged by contact with electrolyte Cardiac Science Corporation recommends using Signa gel electrode gel with reusable sensors because it provides excellent conductivity between the skin and sensor Reusable sensors Welsh bulbs and limb plates must be kept clean Dirt or electrolyte build up may degrade ECG quality Wash after each use use a mild dish soap if necessary Never use a metallic pad to clean plates and Welsh bulbs to avoid damaging the plating Discard if corroded Applying limb plates Caution Patient skin irritation Limb Plates may contain nickel a material that can cause skin irritation Monitor the electrode site and if irritation occurs use an alternate electrode 1 Expose the arms and legs of the patient 2 Connect sensor straps to the ears of the limb plates 6 6 Atria Electrocardiograph Operating Instructions Reusable ECG Sensors 6 Squeeze out a small amount of Signa gel electrode gel on limb plate as illustrated Spread it evenly over th
97. ower 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 Connect the AC power cable to the external power supply Connect the AC power cable to a properly grounded medical grade wall outlet Figure 2 1 Back Panel Key Equipotential Connect equipotential ground cable here See grounding Equipotential Ground on pg 2 1 Power indicator The green LED indicates the Atria is connected to AC power C External power Connect cable from power external power connector 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 At
98. physician Enter up to 15 alphanumeric characters text entry V3 Placement Use only for pediatric reports For more information on pediatric lead placement see Pediatric Lead Placement on pg 6 8 STANDARD V4R Comments Use this field to input additional patient information as needed Enter up to 25 alphanumeric characters text entry Atria Electrocardiograph Operating Instructions 7 9 7 Acquiring ECG Reports 7 10 Atria Electrocardiograph Operating Instructions Chapter Patient Records Working with Patient Records Use the Directory menu to create new patient records access existing records or to work with some or all patient records at once You can use the Directory menu to print a directory report print ECGs create demographic records and delete patient records To access the Directory menu 1 Press Home and then press Directory 2 Press Next or Previous to scroll through the directory options View Entire Patient Directory Lists all the saved patient records View Open Orders Lists only demographic only records no attached ECG View Pending Records Lists only records that have not completed their lifecycle on the device NOTE Pending records are demographic only records records marked as Hold or records that have not been printed if communication is disabled or records that have not been sent if communication is e
99. played Waveform is a bigeminal rhythm QRS amplitude and T wave amplitude are almost the same Incorrect or missing measurements on the printout Undetermined P wave or P T coupling Unusual waveform pattern Atria Electrocardiograph Operating Instructions 10 3 10 Troubleshooting Printing NOTE For information on troubleshooting your plain paper printer refer to the printer s Operator Manual PROBLEM PROBABLE CAUSE Paper jammed or misaligned The Atria not used for extended period of time with paper installed Reload paper see Loading Recording Paper on pg 2 5 Print quality is very light The Atria is being used with unapproved paper Use only Cardiac Science Corporation approved paper Paper type in use is Assurance but paper type selected in system settings is HeartLine Change paper type in settings to Assurance see Paper Type on pg 4 13 Print quality is very dark The Atria is being used with unapproved paper Use only Cardiac Science Corporation approved paper Paper type in use is HeartLine but paper type selected in system settings is Assurance Change paper type in settings to Standard see Paper Type on pg 4 13 Problems using full format paper Load paper see Loading Recording Paper on pg 2 5 Ensure the paper is at top of form by pressing Form Feed and waiting until the paper stops If Out of Paper message is disp
100. ple Setup Report printouts below and following page lists the settings as they are set at the factory rusu SSI ty 600000 O0IEg 2 25 UU LEGU YEL 3HUH ON TANNUHD b GYVONYLS PES CI jeuuo4 440daej 923 dnjas woysng dnouo pee 440 jueue2ueuug J4e2eg NO J84 4 SU euirjeseg 378015 4 1 4 eurjeseg ZH Op 13 1981 42g OL 29 sjwu Ge peeds 195 wyyAyy uud Aug o4ng dn4es PI Ag MBIA Aao 498410 dN4 S WEN SU 87 spiun 445184 NI spiun 1uB18H usi Bu3 ebenBue1 peer cl eull 9007 11 80 8 eq AAAAIGO WN 18UJO3 2120 198195 0 1 SN wass dns vC 8v cl zil 9007 11 80 1u0d3 4 37138 9 3 Atria Electrocardiograph Operating Instructions UU 2EGUYEZ I
101. pplying sensors skin preparation electrolyte solution or electrode material may cause skin irritation Monitor the electrode site and if irritation occurs use alternative electrolyte or electrodes Apply sensors according to the instructions on the following pages for additional lead placement options see Alternative Lead Placements on pg 6 8 For information on using disposable sensors see Disposable Resting ECG Sensors on pg 6 5 For information on using reusable sensors see Reusable ECG Sensors on pg 6 6 NOTE Apply sensors and connect the patient cable and lead wires before entering patient information this allows the sensors to adhere stabilize and improve conductivity Atria Electrocardiograph Operating Instructions 6 3 6 Patient Preparation Resting ECG Lead Placement amp Coding Chart STANDARD LIMB LEADS SENSORS CONNECTED MEASURED LEAD LA RA LEAD LL RA LEAD III LL LA AUGMENTED LIMB LEADS SENSORS CONNECTED MEASURED RA and LA LL LA and RA LL LL and RA LA CHEST LEADS SENSORS CONNECTED MEASURED V and LA RA LL V and LA RA LL and LA RA LL V and LA RA LL Vs and LA RA LL Vg and LA RA LL LEAD CODING AND MEASUREMENTS AHA COLOR CODE LOCATION RIGHT LEG LEFT LEG RIGHT ARM LEFT ARM CHEST RED CHEST YELLOW CHEST GREEN CHEST BLUE CHEST ORANGE CHEST VIOLET IEC COLOR CODE LOCATION BAND RIGHT LEG BLACK LEFT LEG
102. r 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 External communications are optional on the Atria For assistance in determining which options are available on your Atria or to purchase additional options call Customer Service at 800 777 1777 or 608 764 1919 Base communications options include Serial Communications RS232 Wired Ethernet USB Analog Out The following features require the Communications options Email Fax Plain paper printing EMR communications Additional communication options include Internal Fax Modem BlueTooth connection 802 11 network connection PPP connection NOTE Wireless options transmit at 2 4 GHz Other nearby wireless devices may cause interference If possible move or turn off other devices to minimize potential interference Setting up any of the communications options listed above may require assistance from the Network Administrator or IT department Atria Electrocardiograph Operating Instructions 5 1 5 Communications Setup Equipment Connections WARNING Trip hazard Route all cable
103. ria 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 AN 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 Description Action 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 When Low displays immediately battery power and less than 15 connect the Atria to AC power to minutes of operating time remain recharge the battery and prevent The Atria also beeps every 30 operation interruption seconds as an audibl
104. rs Wipe off any residual electrolyte and check again to ensure electrolyte from one site does not touch another site Atria Electrocardiograph Operating Instructions 6 7 6 Patient Preparation Connecting Cables and Lead Wires After applying sensors connect the lead wires from the patient cable to the sensors Make sure the lead cables follow the contours of the patient s body and lie flat Make sure the patient cable is plugged securely into the connector on the front of the Atria see Patient Cable on pg 2 3 Alternative Lead Placements Figure 6 2 Pediatric Chest Lead Placement Pediatric Lead Placement NOTE Refer to Acquiring an ECG Using Pediatric Lead Placements on pg 7 3 for detailed instructions on acquiring an ECG using pediatric lead placement When acquiring a pediatric ECG an alternative to the standard V3 C3 placement may be used Place the sensor in the V4R position This is across the sternum from V See Figure 6 2 for location Improper placement will result in inaccurate waveform labeling Select the corrected V3 C3 placement in the Edit Patient Data display see Enter Patient Demographics on pg 7 2 If is placed in the V R C4R position select V4R for V3 Placement for proper printout labeling Alternate Chest Lead NOTE Refer to Acquiring an ECG Using Alternative Lead Placements on pg 7 6 for detailed instructions on acquiring an
105. rsity 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 AN AN 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 150p 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 W
106. ry default settings 9 3 fax setup 5 10 filter artifact See artifact filter baseline 4 8 data quality 4 5 line 4 8 STABLE Baseline 4 8 filter frequency change current 3 3 frequency response change current 7 5 default setting 4 7 Atria Electrocardiograph Operating Instructions 1 G gain change current 3 3 7 5 default setting 4 7 general features 1 1 GRI See interpretive analysis grounding 2 1 2 2 5 3 H heart rate detection disclosure 11 8 display 3 7 3 10 help menu 1 4 home display 3 7 3 10 hot keys See automatic information entry housing clean and disinfect 11 1 I inspect for damage 11 2 inspection upon delivery 1 1 institution name setting 4 13 intended use v interference 10 3 10 6 10 7 interpretive analysis configure 4 6 general information 1 2 L lead placement alternate chest lead 6 8 pediatric 6 8 standard 12 lead ECG 6 4 leads select custom 3 3 limb plates 6 6 line filter 4 8 low frequency response 4 8 M maintenance 11 1 measurement matrix print report 8 3 sample report 9 8 table key 12 1 median complex print report 8 3 sample report 9 9 medical grade power supply 2 2 2 3 miscellaneous settings 4 13 modem connect 5 2 multiple electrical apparatus 1 3 muscle artifact 10 5 N network setup 5 3 O options configure 4 1 overload condition 10 2 10 5 P pacemaker detection a
107. s 11 14 Measurement Matrix 12 1 2 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 AN AN AN AN 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 defi
108. s Date of Birth automatically enters Age and Age Format Age 3 numeric characters range 0 129 text entry years 0 99 months 0 365 days Not editable if Date of Birth was entered Age Format Not editable if Date of Birth was entered YEARS MONTHS DAYS Gender Enter the gender of the patient blank MALE FEMALE Atria Electrocardiograph Operating Instructions 7 7 7 Acquiring ECG Reports Race Enter the patient s race blank BLACK CAUCASIAN ASIAN OTHER RACE UNKNOWN Medication 1 Select medication taken by the patient blank NO MEDICATION UNKNOWN DIGITALIS DIURETIC BETA BLOCKER QUINIDINE PROCAINAMIDE AMIODARONE DISOPYRAMIDE LIDOCAINE OTHER ANTIARRHYTHMIC PSYCHOTROPIC STEROID CALCIUM BLOCKERS NITRATES ACE INHIBITORS ALPHA BLOCKERS OTHER MEDICATION Medication 2 This field is not displayed if Medication 1 is left blank or NO MEDICATION UNKNOWN OTHER MEDICATION is selected see MEDICATION 1 list above Class 1 Patient s cardiac lung or endocrine conditions For ECG waveform analysis it is better to select NORMAL or UNKNOWN than to leave this field blank blank NORMAL UNKNOWN MYOCARDIAL INFARCTION MYOCARDIAL ISCHEMIA HYPERTENSION CONGENITAL HEART DISEASE RHEUMATIC HEART DISEASE PERICARDITIS RESPIRATORY DISEASE IMPLANTED PACER ENDOCRINE DISEASE PULMONARY EMBOLISM POST CARDIAC SURGERY CARDIOMYOPTHY OTHER
109. s away from main work areas to minimize risk of tripping and injury Figure 5 1 Back Panel Key A Modem RJ11 port to connect telephone cable 0 Network RJ45 port to connect network cable NOTE Donotinsert the telephone cable in the Network port C USB host USB type A port to connect USB printer or USB wireless adapter D Serial RS 232 a 9pin serial port to connect external fax modem or direct connection to management system Analog Analog port to connect a monitor or other device Contact output Technical Support for approved cables Y The Atria conforms to the all safety and essential performance standards Every effort has been made to ensure the Atria will be safe when used with systems containing other equipment When Atria is connected to another device using a USB cable it is important to ensure the cable will not create excessive radio frequency emissions To minimize this risk a ferrite cable emissions reducer p n 040 1508 00 is available as an Atria accessory see the Accessories List for ordering instructions and must be used with any USB cable connected to the Atria Follow the installation instructions supplied with the ferrite cable emission reducer 5 2 Atria Electrocardiograph Operating Instructions Grounding Grounding All connected equipment must be IEC 60950 approved or equivalent Consult a qualified technician to verify equip
110. s set to ON e Press Home then press ECG twice The Atria automatically prints the ECG on the default printer To configure the default printer select Setup gt Printer gt Default Printer Atria Electrocardiograph Operating Instructions 5 9 5 Communications Setup Setup Fax WARNING A Misdiagnosis Records sent by fax may not be suitable for diagnostic use due to the low resolution of some fax receiving equipment Enter up to four 20 digit fax numbers include outside line access number if necessary 1 Connect telephone line to the RJ11 port NOTE See Equipment Connections on pg 5 2 for Atria connection diagrams The modem will not work if phone cord is connected to the network port Press Home and then press Setup Select Send Receive gt Setup Fax gt Enabled and then select either TOUCH TONE or Pulse For each fax enter a fax number and description Verify fax operation a Press Home then press ECG twice b Select Fax ECG c Select the fax destination and verify the receiving fax machine successfully prints out the ECG Setup Email WARNING A Misdiagnosis ECG reports images viewed or printed in pdf format at a size other than 100 may be appear distorted Network setup is required in order to use the email option See Network Setup on pg 5 8 Refer to Equipment Connections on pg 5 2 e For Ethernet network connect to network via RJ45 port For 802
111. sors Figure 6 1 Disposable Limb Sensor on Arm CardioSens disposable sensors are more effective than bulbs plates straps creams and gels CardioSens disposable sensors reduce cross contamination and infection and improve diagnostic results Disposable sensors must be stored according to the guidelines on the packaging and must not be used after the expiration date Always store opened packages of disposable sensors in a sealed container to avoid contamination and quick dry out Orient the sensors to minimize twist stress when the clip and lead wire is attached Caution Baseline drift Never mix patient electrode types or brands Dissimilar metals or other incompatibilities may cause considerable baseline drift and may increase trace recovery time after defibrillation Applying Limb Sensors 1 Expose arms and legs of the patient 2 Place sensors firmly on the prepared limb sites Choose fleshy areas above the inside wrists and ankles not on the bone see Figure 6 1 Point arm sensor leads toward the elbow Point leg leads toward chest 3 Clip leads to the sensors Ensure the leads do not pass twist stress onto the electrodes Applying Chest Sensors 1 Expose the patient s chest 2 Locate the six V lead or C lead positions on the patient s chest See Resting ECG Lead Placement amp Coding Chart on pg 6 4 3 Apply the sensors firmly on the prepared chest lead placements ensur ing the leads c
112. t guarantee against the failure or deterioration of components due to aging and normal use Performance Disclosures AN AN WARNING Explosion hazard Do not use in the presence of flammable anesthetics other gasses that support combustion or in a high oxygen atmosphere WARNING Patient injury or death Do not use the Atria for unattended or continuous patient monitoring The Atria has no audible or visible alarms and change to patient condition may not be immediately known The Atria is only intended for short term ECG waveform acquisition WARNING Electromagnetic interference Position the Atria away from other electrical or electronic equipment if possible 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 may cause trace noise or input overload conditions 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 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 Atria Electrocardiograph Operating Instructions 11 7 11 Maintenance and Service
113. ter a few seconds the Atria displays a list of one or more custom headers Atria Electrocardiograph Operating Instructions 5 18 5 Communications Setup 3 Select the appropriate custom header The Atria prompts to restart NOTE Ifthe Atria reports errors the communications log contains more information regarding the errors To print the communications log Press Setup and then select Print Communications Log For more information press ALT H to access the Help menu and select Troubleshooting gt Communications 4 Press any key The Atria restarts with the new custom header The Atria is ready to communicate with the EMR System 5 14 Atria Electrocardiograph Operating Instructions Chapter 6 Patient Preparation AN AN WARNING Explosion hazard Do not use in the presence of flammable anesthetics other gasses that support combustion or in a high oxygen atmosphere 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 and the patient cable 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
114. the paper must be parallel to the lines printed on the paper door Atria Electrocardiograph Operating Instructions 2 5 2 Equipment Setup Slide the door into place until it clicks 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 1s Assurance If using HeartLine paper see Paper Type on pg 4 13 to change the setting 2 6 Atria Electrocardiograph Operating Instructions Chapter 3 User Interface The Atria user interface consists of an LCD display and keyboard There are two versions of the Atria keyboard Both versions are illustrated below Figure 3 1 User Interface Keyboard Version 1 e S a a ASH ee f 5550 F Patient Directory Send Rec Setup Sensor m 6 f N x Sp fl 2 E 4 7 8 E my mE i di nao ESS Atria 6100 Atria 3100 Atria Electrocardiograph Operating Instructions 8 1 3 User Interface Figure 3 2 User Interface Keyboard Version 2 cD Paint f Diretory 5 i
115. this information must be provided to the telephone company The REN is used to determine the quantity of devices that may be connected to the telephone line Excessive RENs on the telephone line may result in devices not ringing in response to an incoming call In most but not all areas the sum of the RENs should not exceed five 5 0 To be certain of the number of devices that may be connected to the line as determined by the total RENs contact the telephone company to determine the total REN for the calling area If your Atria causes harm to the telephone network the telephone company will notify you in advance that temporary discontinuance of service may be required But if advance notice isn t practical you will be notified as soon as possible Also you will be advised of your right to file a complaint with the FCC if you believe it is necessary The telephone company may make changes in its facilities equipment operations or procedures that could effect the operation of the equipment If this happens the telephone company will provide advance notice in order for you to make the necessary modifications in order to maintain uninterrupted service If you experience trouble with your Atria please contact Cardiac Science Corp at 800 777 1777 or 608 764 1919 for repair warranty information If the trouble is causing harm to the telephone network the telephone company may request you remove the equipment from the network until the probl
116. ting 3 Select the Default Printer Thermal Atria Plain Paper external printer FOR LOCAL PRINTERS ONLY 4 Select Printer Type PCL3 DeskJet Postscript PCL5 LaserJet 5 Select Find Local Printers Do NotFind Local Printers 5 8 Atria Electrocardiograph Operating Instructions External Printer Setup Start Find Local Printers This starts the process to find local printers The Atria automatically selects the printer If the Atria finds more than one printer use the navigation buttons to select the printer and then press Select FOR NETWORKED PRINTERS ONLY 6 Enter the Printer IP address 7 Select Printer Type PCL3 DeskJet Postscript PCL5 LaserJet Printer Connection 1 Setup the printer per manufacturer s instructions 2 Connect printer to Atria Refer to Equipment Connections on pg 5 2 Ethernet network Connect network cable to RJ45 port printer must also be connected to network Wireless network Connect the 802 11 USB adapter USB printer Connect to USB port BlueTooth printer Connect BlueTooth adapter to USB port PPP network For an internal modem Connect the phone cable For an external modem Connect the modem and phone cable Verify Printer Operation NOTE In order to perform this procedure the patient cable must be plugged in and Setup gt ECG gt Sequence gt Auto Print is set to ON and Setup gt ECG gt Sequence gt Auto Save i
117. to both User 1 and User 2 For more information on configuring users see Multiple Users on pg 4 1 Date Format Select the format for current date and date of birth MM DD YYYY DD MM YYYY YYYY MM DD Date Enter the current date text entry Time Enter the current time using a 24 hour format text entry NOTE The time setting must be updated during a time change e g Daylight Saving Time If the communications option is installed and configured then update the time zone GMT too For more information see the note about UTC GMT Time Zone Offset on page 5 4 Height Units Select the units to use for patient height IN IN Inches CM CM Centimeters Weight Units Select the units to use for patient weight LB LB Pounds KG KG Kilograms Inst Name Enter the medical facility name up to 30 characters The text entry information displays at the bottom of each printout Paper Type Select the type of paper to automatically set the correct Assurance printing contrast HeartLine Paper Size Select the size of the paper A 8 5 x 11 A4 Administrative Set an administrative password to restrict Setup menu ON Password settings OFF When set to ON the system prompts for a password enter password up to 15 characters Atria Electrocardiograph Operating Instructions 4 13 4 User Settings System Menu Items Description Selections Directory Set a directory p
118. trocardiograph Operating Instructions Network Setup 3 Enter the following a When DHCP is OFF enter IP address IP Address for the Atria typically assigned by the network administrator Subnet Mask typically 255 255 255 0 Gateway IP address for the Gateway b Select appropriate options based on the Wireless Security settings Refer to the table below Wireless Security Setting Options Setting None Wireless SSID Wireless Channel UTC GMT Time Zone Offset WEP Wireless Authentication Wireless SSID Wireless Channel Encryption key 1 Encryption key 2 Encryption key 3 Encryption key 4 UTC GMT Time Zone Offset WPA or WPA2 Personal Wireless SSID WPA WPA2 Passphrase UTC GMT Time Zone Offset Supplicant Config UTC GMT Time Zone Offset For more information on configuring and alternative security option see Security Settings Supplicant Configuration on pg 5 6 WPA or WPA2 Enterprise Wireless SSID WPA WPA2 Enterprise ID WPA WPA2 Enterprise Password UTC GMT Time Zone Offset The Wireless SSID and the WPA WPA2 Passphrase is either SSID or DSSID as configured on the wireless access point The Wireless Channel is configured on the wireless access point WPA WPA2 Enterprise ID and the WPA WPA2 Enterprise Password is configured on the RADIUS Authentication server See the Time Zone instructions and note on 5 4 for configuring the UTC GMT Time Z
119. u or display or to move the cursor within an edit field Atria 6100 only Select Leads Press Press or or 8 to select the lead em triplet indicated on the key for rhythm display and printouts Press amp or to select user defined leads Custom Lead 1 and Send Records Custom Lead 2 respectively The selected leads will be printed on manual Press for send record options e hythm and auto rhyth orts EN ae BORD Yee Select desired options Send All New or Selected ECGs Change Settings Select Records to Send NOTE Communications option must be installed and configured to use this fea 7 ture Press mus to change current speed setting Configure System Settings Press to change current gain setting Press to configure system settings Press e yz to change current artifact filter setting s Use the navigation buttons to select the Setup category Press to add a calibration pulse to the printout manual or auto Help to view the Help menu and print out help pages rhythm printouts only m Press Show Sensor Status Atria 3100 only Press to display status of sensors v CARDIAC SCIENCE Bothell Washington 98021 8969 U S A 608 764 1919 073 0159 00 E Chapter 1 General Information Inspection at Delivery Please inspect the Atria for any shipping damage Ifthe Atria was damaged during shipment contact your shipping agent Ifanitem is missing cont
120. ugh to support both arms and legs Arms should rest at the side and the legs should lie flat and not touching Support the head with a pillow Avoid cold drafts and cover the patient with a blanket to prevent shivering leave the chest and sensor sites exposed Skin Preparation Refer to the Resting ECG Lead Placement amp Coding Chart on pg 6 4 for details on where sensor sites are located For information on alternate chest lead and other lead placements see Alternative Lead Placements on pg 6 8 1 Usethe thumb and forefinger to part hair when necessary Clipping or shaving may be required 2 If skin has lotion on it or the patient 1s diaphoretic clean skin with alcohol and abrade slightly with a dry gauze 3 Ensure the skin is completely dry 6 2 Atria Electrocardiograph Operating Instructions Sensor Application Sensor Application AN AN AN AN WARNING False Readings The lead status check does not detect lead reversals Always ensure the correct lead placement is used for the lead configuration selected WARNING Misdiagnosis Dirty compromised or unprepared skin may cause incorrect readings Before applying sensors ensure the skin is clean unbroken and properly prepared WARNING Infection Lead placement on compromised skin may cause infection Before applying sensors ensure the skin is clean unbroken and properly prepared Caution Patient skin irritation When a
121. urrent Page Available Displays the current page followed by the total Pages number of pages in the current menu D Navigation Displays the acceptable navigation selections Previous gt Next Select If the Home screen is not displayed press Home Press Patient Press Select to display the Patient ID entry field Enter patient information and press Select The next entry field auto matically displays Her Cr ch a NOTE review or change an entry press the Back key or use Previous or Next and to scroll to a field and then press Select to enter or change the information 5 When all demographic information is entered press Home to return to the Home screen Atria Electrocardiograph Operating Instructions 8 11 3 User Interface 3 12 Atria Electrocardiograph Operating Instructions Chapter 4 User Settings Overview The Settings menu sets defaults for each use For example to default toa gain of 5 mm mV press Setup then select Waveform Preferences gt Gain gt 5 mm mV For each use the gain will default to 5 mm mV Multiple Users Most Atria settings except for system settings and communication settings can be configured for either User 1 or User 2 For example if the Atria used by two different doctors Dr Miller Brief format interpretation two copies of the ECG ECG speed of 12 5 mm sec and gain of 5 mm mV Select User 1 and enter Dr
122. y Leakage current Defibrillation protection Equipment Type Degree of protection from electric shock Mode of operation Schematics Warranty 50 F to 104 F 10 C to 40 C 20 to 75 non condensing 1060 hPa to 700 hPa 500 ft to 10 000 ft reference to sea level 4 F to 113 F 20 C to 45 C 10 to 90 non condensing 1060 hPa to 190 hPa 500 ft to 40 000 ft reference to sea level Normal Ethernet RJ45 USB type A Standard RS 232 9 pin D Analog output 3 5 mm phono plug 802 11 Bluetooth Telephone line interface RJ11 CAN CSA C22 2 No 0 M91 CAN CSA C22 2 No 601 1 M90 CAN CSA C22 2 No 601 151 CSA C22 2 No 601 2 25 UL 60601 EN 60601 1 EN 60601 2 25 amp Amend 1 EN 60601 1 2 AZINZS 2064 1 2 ANSI AAMI 11 1991 EN 60601 2 51 patient 10 pA chassis 100 pA to 5000V 360J Class lla Council Directive 93 42 EEC MDD IEC 60601 1 Class II Type CF Defibrillator Proof Continuous Available on request 3 years with return of warranty card Atria Electrocardiograph Operating Instructions 11 15 11 Maintenance and Service 11 16 Atria Electrocardiograph Operating Instructions Chapter T Measurement Matrix Atria models with interpretation and measurement capabilities also have the Measurement Matrix printing option This option is available after acquiring the ECG via the Patient Review menu see also How to Display a Patient Record on pg 8 2 to
123. y grounded wall outlet Arrange the patient cable leads together closely following the body contour Turnon line filter Check Setup and then select Waveform Preferences gt Line Filter For more information see Line Filter on pg 4 8 Ensure Diathermy or X ray equipment in adjacent rooms is not operating Other electrical equipment including electric beds televisions and lighting fixtures may also generate interference even when not in use Try moving the patient to another place in the room Sometimes electrical wiring in walls and ceilings causes interference Operate the Atria from battery power Atria Electrocardiograph Operating Instructions 10 7 10 Troubleshooting 10 8 Atria Electrocardiograph Operating Instructions Chapter 11 Maintenance and Service Cardiac Science Corporation recommends performing the following routine maintenance procedures per the schedule listed or as needed Once per Shift Clean and Disinfect Clean and disinfect the Atria at least once per shift or as needed Caution Equipment damage Do not use ether bleach acetone benzene or similar A solvents to clean the Atria cables or sensors Only use the following cleaning agents 3M 23H PDI Nice Pak Sani System or Virex II Caution Equipment damage Do not immerse the Atria cables or sensors in any type of fluid If the Atria is immersed in or comes in contact with large qua

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