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Schiller CARDIOVIT AT-1 G2 User Manual Download Page 58

12

Technical Data

12.3 Safety Standards

Page 58 

CARDIOVIT AT-1 G2

A

rt.

 no.

: 2.

511

235 Rev.:

 d

12.3 Safety Standards

Safety standard

IEC/EN 60601-1
IEC/EN 60601-2-25

EMC

IEC/EN 60601-1-2

Protection class

Device as a system: Class I in accordance with IEC/EN 60601-1

Conformity/classification

CE/IIa in accordance with directive 93/42/EEC

Protection

This device is not designed for outdoor use (IP 20) 

Summary of Contents for CARDIOVIT AT-1 G2

Page 1: ...1 1 1 1 1 CARDIOVIT AT 1 G2 User guide Art no 2 511235 Rev d 2 511235 ...

Page 2: ...iaries is provided on our internet site www schiller ch Sales information can also be obtained from sales schiller ch The CARDIOVIT AT 1 G2 bears the CE 0123 mark Notified Body TÜV SÜD Produkte Service GmbH Ridlerstr 65 80339 Munich Germany indicating its compliance with the essential require ments of the Annex I of the Medical Device Directive 93 42 EE regarding safety functionality and labelling...

Page 3: ...ols used in this document 11 1 11 2 Symbols used on the device 12 2 Overview 13 2 1 Main Components of the CARDIOVIT AT 1 G2 13 2 1 1 Standard 13 2 1 2 Options 13 2 2 Keyboard 14 2 2 1 Description of keys 14 2 3 Display 15 3 Operation 16 3 1 Initial operation 16 3 1 1 Location 16 3 2 Connections 16 3 2 1 Back panel 16 3 2 2 Right hand side panel 17 3 2 3 Connection of external cable assemblies 17 ...

Page 4: ... recording 31 6 2 1 Printout 32 6 3 Manual Rhythm Printout 33 6 3 1 Starting manual printout 33 6 4 Changing the ECG display 34 6 4 1 Display 34 6 4 2 Myogram filter 34 6 4 3 Other filters 34 7 Culprit Coronary Artery Algorithm 35 7 1 Introduction 35 7 1 1 Culprit Artery Algorithm Decision Overview 36 7 1 2 Starting the CCAA analysis 37 7 1 3 CCAA information on print preview printout 38 8 PDF exp...

Page 5: ...nts 47 10 3 2 Non admissible disinfectants 47 10 4 Cleaning the print head 47 10 5 Battery 48 10 5 1 Charging the battery 48 10 5 2 Battery disposal 48 10 6 Inspection Report 49 10 6 1 Lifed item replacement every 3 5 years 50 10 7 Accessories and disposables 51 11 Trouble Shooting 52 11 1 Possible problems 52 11 2 Preventing electromagnetic interferences 54 11 2 1 Measures to prevent electromagne...

Page 6: ...Art no 2 511235 Rev d Contents Page 6 CARDIOVIT AT 1 G2 ...

Page 7: ...and paediatric patients The unit is not intended for sterile use use in potentially explosive areas or in the presence of flammable gases such as anaesthetic agents direct cardiac application use in an MRI suite The CARDIOVIT AT 1 G2 must only be used by qualified medical personnel The numerical and graphical results and any interpretation given must be examined with respect to the overall clinica...

Page 8: ...arthed Immediately report any changes that impair safety including operating behaviour to the responsible person Do not place any liquids on the unit If liquid is spilled on the device immediately disconnect the device from the mains and wipe it The device must be checked before reusing Only connect the original SCHILLER patient cable to the patient socket If the patient cable should become defect...

Page 9: ...terference during ECG acquisition However the stimulation units should only be used at a sufficient distance from the electrodes and both devices must be connected to the same potential equalisation If in doubt the patient should be disconnected from the device There is no danger for patients with a pacemaker There is no danger when using this unit simultaneously with electrical stimulation equipm...

Page 10: ...ive send it to your local SCHILLER representative or directly to the manufacturer The manufacturer can only be held responsible for the safety reliability and performance of the apparatus if assembly operations extensions readjustments modifications or repairs are car ried out by persons authorized by the manufacturer and the SCHILLER device and approved attached equipment is used in accordance wi...

Page 11: ...personal injury or to death For a possibly dangerous situation which could lead to severe personal injury or to death For a possibly dangerous situation that could lead to personal injury This symbol is also used to indicate possible damage to property For general safety notes as listed in this chapter For electrical hazards warnings or precautionary measures when dealing with electricity Note For...

Page 12: ... recognition of electrical and electronic equipment Equipment components and accessories no longer required must be disposed of in a municipally approved collection point or recycling centre Alternatively you can re turn the equipment to your supplier or the manufacturer for disposal Improper dis posal can harm the environment and human health The unit component can be recycled 0123 Notified Body ...

Page 13: ...ice settings The CARDIOVIT AT 1 G2 has the following features 2 1 Main Components of the CARDIOVIT AT 1 G2 2 1 1 Standard Pacemaker detection Manual rhythm printout in real time leads speed and amplitude can be changed Auto mode recording 10 seconds with user defined print formats Measurements Display of all 12 channels 4x3 Display of reversed electrodes Recording review PDF export to USB stick 2 ...

Page 14: ...trieved Printing an ECG from the Preview screen Unless new patient data has been entered additional printouts copies can be generated Changing the myogram filter Off 25 40 or 150 Hz Once the recording is completed the filter is reset to the value programmed in the menu Filter formulas see page page 41 Setting the ECG chart speed and amplitude Menu Enter key and Up down keys To enter a dot or dash ...

Page 15: ...p down keys Speed amplitude Myogram filter Notch filter Battery capacity status green mains operation black battery operation USB stick Main menu 28 08 2016 17 58 next previous select close Filters formulas ECG Preview Print formats SYSTEM Settings Info Leads cable Patient cable IEC or AHA Signals Simultaneous Lead sequence Cabrera Print interpretation Menu Enter key to open main menu parameter ch...

Page 16: ... Potential equalisation stud The potential equalisation stud is used to equalise the ground potential of the unit to that of any nearby mains powered equipment Use the hospital or building common ground for all mains powered units 3 USB interface for USB memory stick 4 Kensington lock Electrical shock hazard Do not operate the unit if the earth connection is suspect or if the power supply unit mai...

Page 17: ... to ensure a secure connection 2 Connect the mains cable at the rear of the unit The mains indicator LED is lit 3 Leave the CARDIOVIT AT 1 G2 connected to the mains for 3 hours to fully charge the battery 4 Connect the potential equalisation cable 5 Connect the patient cable side panel The potential equalisation stud at the back of the unit is used to equalise the ground potential of the CARDIOVIT...

Page 18: ...0 minutes a dialogue is displayed in which switching off can be cancelled by pressing Turn off device Do you want to switch off the device YES NO 1 When the mains supply is connected the mains LED is lit 2 The battery LED is blinking when the battery is being charged and it is lit when charging is complete During battery operation no mains connected both LEDs are off The status is indicated as fol...

Page 19: ... paper is to be used Store the paper in a cool dark and dry location Do not store near chemicals e g sterilisation liquids Do not store in a plastic cover Certain glues can react with the paper Therefore do not use glue to attach the printout onto a mounting sheet SCHILLER can only guarantee perfect printouts when original SCHILLER chart paper or chart paper of the same quality is used 1 Open the ...

Page 20: ... ECG settings Page 20 CARDIOVIT AT 1 G2 Art no 2 511235 Rev d 3 6 System and ECG settings The system settings time date device ID etc and other general settings are de scribed on page 41 The ECG settings are described on page 41 ...

Page 21: ...gel is between the elec trode and the skin 4 Check the electrode resistance as described in the section 4 5 5 If the electrode resistance is higher than the acceptable level Remove the electrode and use an abrasive cleaning pad or abrasive cleaning gel 2 to remove the uppermost layer of epidermis Apply the electrode Always use a new disposable electrode 6 Ensure that the patient is warm and relaxe...

Page 22: ...ics and to Code 2 AHA in the tables IEC AHA IEC label Colour AHA label Colour R Red RA White Limb L Yellow LA Black F Green LL Red C1 White red V1 Brown red Chest C2 White yellow V2 Brown yellow according C3 White green V3 Brown green Wilson C4 White brown V4 Brown blue C5 White black V5 Brown orange C6 White purple V6 Brown purple Neutral N Black RL Green The patient cable type IEC or AHA is set ...

Page 23: ...el AHA label Connecting the ECG patient cable C1 red V1 red Fourth intercostal space at the right sternal border C2 yellow V2 yellow Fourth intercostal space at the left sternal border C3 green V3 green Midway between sites C2 and C4 C4 brown V4 blue Fifth intercostal space on the mid clavicular line C5 black V5 orange Anterior axillary line on the same horizontal level as C4 C6 purple V6 purple M...

Page 24: ...C6 Violet C5 black F green L yellow C4r Brown IEC Label AHA Label Connecting the ECG patient cable C1 white red V1 brown red Fourth intercostal space at the right sternal border C2 white yellow V2 brown yellow Fourth intercostal space at the left sternal border C3 white green V3 brown green Midway between C2 and C4 C4r white brown V4 brown blue Fifth intercostal space on the mid clavicular line C5...

Page 25: ...des off electrode is highlighted in colour The electrode status is shown in the top right of the screen If an electrode is displayed in colour the suspected cause is displayed The electrode needs to be checked and re applied if necessary If F LL or N is not connected or has come off the electrode resistance cannot be measured and all leads are marked red 12345 28 10 2016 17 58 25 mm s 10 mm mV LP ...

Page 26: ...abrera lead sequence The lead sequence is defined in the ECG menu Key Menu ECG Leads cable In the Lead menu select between Standard and Cabrera Main menu 28 08 2016 17 58 change confirm Filters formulas ECG Preview Print formats SYSTEM Settings Info Leads cable Patient cable IEC Signals Simultaneous Lead sequence Cabrera Print interpretation PDF formats ...

Page 27: ... option is licensed 2 Select the desired parameter using the keys 3 Press the Menu Enter key to access the setting 4 Use the dual function keys to enter numerical values or use the keys to select the correct setting 5 Press the Menu Enter key to confirm and access the next setting Use the Stop key to exit the patient data menu If the key is pressed twice the previous patient s data is retrieved To...

Page 28: ...d yyyy Gender Enter the patient s gender Male or Female or Undefined Pacemaker Select if the patient has a pacemaker Yes No Unknown Regardless of this setting detected pacemaker pulses are indicated in blue and the interpretation states that it is a pacemaker ECG Activate CCAA option Activating a CCAA recording by entering the following Prior Bypass Stent Yes No Chest pain for h For more details s...

Page 29: ...is suspect or if the mains lead is damaged or suspected of being damaged If the CARDIOVIT AT 1 G2 is used together with other electronic devices use the potential equalisation stud for earth protection If another format than the default format is set for the automatic printout the printout can differ from the format displayed on the screen The standard values for the display and thermal printer ar...

Page 30: ...G data including calculated average values measurements and interpretation The recording can be checked using the keys The recording can be printed and saved internally as PDF or it can be discarded Basic settings Lead configuration ECG cable Patient data Activate CCAA option Prepare the patient connect the electrodes and switch on the device Check the signal Filter settings Select filter Off 25 4...

Page 31: ... The recording can be reviewed Use the keys to toggle between the following 6 pages Rhythms I II III Rhythms aVL aVL aVR Rhythms V1 V2 V3 Rhythms V4 V5 V6 Interpretation Measurements Auto 12345 28 08 2016 17 58 25 mm s 10 mm mV LP 150Hz AC 50 Hz I II III 60 min Review 25 mm s 10 mm mV LP 150Hz AC 50 Hz 14 03 2017 17 58 HR 60 min RR 1000 ms QRS 94 ms P 116 ms QT 416 ms PQ 172 ms QTc 416 ms P 46 QRS...

Page 32: ...d Blood pressure needs to be written by hand Medication needs to be written by hand Remark needs to be written by hand Speed Sensitivity Filter Device ID Device serial number Software version And any combination of the following for printout settings see page 42 Rhythm ECG recording of all 12 channels in either Standard or Cabrera format according to selection Averaged cycles Averaged cycles with ...

Page 33: ...ect sensitivity To change the printout amplitude 5 10 and 20 mm mV press the corresponding key Stopping the printout To stop the manual recording printout press the Stop key The printout provides the following information Selected leads Heart rate averaged over four beats Patient ID if entered Name written by hand on the printout Date and time Speed Sensitivity Filter Device name Device serial num...

Page 34: ... prevents recording interference due to mains frequency oscillation If the filter is active AC 50 Hz or AC 60 Hz is displayed The ECG display is optimised for one column of 3 channels and cannot be changed The amplitude and speed can be changed at any time with the direct keys The standard values for the display and thermal printer are 25 mm s and 10 mm mV Lead sequence Lead group 1 Lead group 2 L...

Page 35: ... risk The algorithm indicates the location of the occlusion site and issues a recommendation based on the ECG data and patient history The recommendation is based on the following Prior Bypass Stent This data is entered before the ECG recording is taken see section 6 1 Resting ECG Procedural Flow Diagram page 30 If the patient has had prior bypass or stent the ECG is not analysed further and the a...

Page 36: ...r limit ST Score upper limit YES ST Score upper limit YES YES YES ST Score upper limit PCI centre consider thrombolytic therapy if PCI Centre is further away than xx hours Nearest Hospital Consider thrombolytic therapy ST Score upper limit PCI centre consider thrombolytic therapy if PCI Centre is further away than xx hours Nearest Hospital Consider thrombolytic therapy Nearest Hospital Consider th...

Page 37: ...ached in position C4r precordial see section 4 4 Standard with C4r for CCAA recordings page 24 1 Enter the patient data 2 Activate CCAA by selecting Yes 3 Enter the additional parameters Bypass stenting and time since chest pain started 4 Check the electrode placement V4r and record the ECG Patient ID Gender Pacemaker Patient data 25 01 2018 17 58 Female No Date of Birth next previous select close...

Page 38: ... coronary artery LAD Prox left anterior descending LAD Dist left anterior descending RCA Prox right coronary artery RCA Dist right coronary artery LCX left circumflex artery 3V LM narrowing all three vessels or left main is affected Advice Recommendations based on the ST score and additional information Transport to PCI centre Transport to nearest hospital Consider thrombolytic therapy if PCI cent...

Page 39: ...n if it is not used Activate PDF export in Menu PDF formats If PDF export is active the ECG is automatically stored on the device see section 9 2 6 PDF formats page 42 The PDF s content can be defined in the same menu 1 Connect the USB stick on the back of the device If there are any stored recordings these are automatically exported to the USB stick This procedure can be cancelled by pressing the...

Page 40: ...keys next previous 3 Press the key select to access the sub menu 4 Press the key select to access the setting 5 Use the dual function keys to enter numerical values or use the keys change to select the correct setting 6 Press the key confirm to get to the next parameter 7 Press the key back to return to the main menu 8 Press the key close to return to the ECG screen the settings are saved Main men...

Page 41: ...intouts If Simultaneous is selected the same time segment is used for all lead groups this applies for printouts If a print format with a rhythm lead is defined Sequential is used even if you have selected Simultaneous Lead sequence Standard or Cabrera Menu Parameter Description selection Filters formulas Notch filter Off AC 50 AC 60 Hz Myogram filter LP 25Hz LP 40Hz LP 150 Hz Off 250Hz QTc calcul...

Page 42: ... s 2 rhythms 25 mm s Rhythm lead 1 I II V5 V6 Rhythm lead 2 I II V5 V6 Markings On Off Measurements On Off Menu Display Description Interpretation Interpretation On Off Unconfirmed report On Off Abnormal ECG On Off Menu Display Description PDF export On Off PDF formats ECG printout 4x3 1 25 mm s 1 page 2x6 25 mm s 1 page 2x6 50 mm s 1 page Off Rhythm lead 1 I II V5 V6 Average cycles Off 4x3 25 mm ...

Page 43: ...fo Software and hardware versions are displayed Menu Parameter Settings Language Select a language Date format dd mm yyyy yyyy mm dd or mm dd yyyy Date Enter the date Set Time 24h Enter the time Displaying the parameter Simulation ECG to activate simulated ECGs is described in the service manual and only serves demonstration purposes ...

Page 44: ... the manufacturer s instructions The test results must be recorded and compared to the values in the accompanying documents Maintenance work not described in this section may only be performed by a qualified technician authorised by SCHILLER AG The following table indicates the intervals and responsibilities of the maintenance work required Local regulations in your country may stipulate additiona...

Page 45: ...liquid and do not sterilise it with hot water steam or air Do not autoclave the unit or any accessories Do not immerse the device in liquid Do not spray liquid onto the device cable The use of detergents with a high acid content or detergents that are otherwise unsuitable can damage the device i e cracks and wear of the plastic casing Always follow the usage instructions provided by the manufactur...

Page 46: ...e cable and slide the cable through the cloth 20 cm at a time until clean Do not clean the whole length in one single action as this may cause bunching of the insulation sheathing 4 Thoroughly wipe off any excess cleaning solution Do not let the cleaning solution run into or accumulate in connector openings switches or gaps If liquid gets into connectors dry the area with warm air 10 2 2 Admissibl...

Page 47: ...use products containing the following Organic solvents Ammonia based detergent Abrasive cleaning agents 100 alcohol Conductive solution Solutions or products containing the following ingredients Acetone Ketone Quaternary ammonium compound Betadine Chlorine wax or wax compound Sodium salt 10 4 Cleaning the print head Over a period of time the printing ink from the grid on the paper can form a film ...

Page 48: ...a fully charged battery is stored for a long period of time this may reduce its service life 10 5 1 Charging the battery A totally discharged battery requires approximately 4 hours to be 90 charged when the unit is switched off It is possible to use the unit when the battery is being charged however the charging time may be longer No harm will be done to the battery by leaving the unit connected t...

Page 49: ...ecommended inspection interval Every 6 months Test Results Date Visual inspection 10 1 External condition Casing not damaged Electrode connector port not dam aged Availability and condition of ac cessories ECG Electrodes expiration date and compatibility User guide Mains and patient cable Functional test 2 2 ECG test No error message shown in the standard display Keyboard test Keyboard is working ...

Page 50: ...1235 Rev d 10 6 1 Lifed item replacement every 3 5 years Inspection Results Replacement Internal battery Replace Internal Accumulator if operation falls substantially under one hour Unit sent to SCHILLER service centre for accumulator replace ment Date of replacement Inspector ...

Page 51: ...e the warranty Art no Article 2 310320 Earth cable for the potential equalisation stud 2 400095 10 wire patient cable IEC 3 5 m push button 2 400104 10 wire patient cable AHA 3 5 m push button 2 400070 10 wire patient cable IEC 2 m banana plug 2 400071 10 wire patient cable AHA 2 m banana plug 2 000041 Electrode kit for adults 2 000052 Electrode kit for children 2 155025 Blue Sensor disposable ECG...

Page 52: ...ck the electrode resistance all leads need to be shown in green Re apply the electrodes Ensure that the patient is relaxed and warm Check all filter settings Menu key Filter formulas Activate the myogram filter and change the cut off frequency Ensure mains filter is correct for mains supply If the problem persists call your local SCHILLER representative Specific devices labelled with the symbol ma...

Page 53: ...n and measurement options are ena bled for the printout See page 42 sections 9 2 4 and 9 2 5 Keyboard blocked Software hangs up Switch off and on again after a few seconds Press and hold the On Off button for 10 seconds to force the device to switch off Reconnect mains and switch on If the problem persists call your local SCHILLER representative Error Possible causes and indicators Error localisat...

Page 54: ...mitter fre quency MHz Testing fre quency MHz Max power P W Distance d m Various radio services TETRA 400 380 390 385 1 8 0 3 Walkie talkies FRS Rescue service police fire brigade servicing GMRS 430 470 450 2 0 3 LTE band 13 17 704 707 710 745 780 0 2 0 3 GSM800 900 LTE band 5 Radio telephone microcellular CT1 CT2 CT3 800 960 810 870 930 2 0 3 GSM1800 1900 DECT radio telephone LTE Band 1 3 4 25 UMT...

Page 55: ...es Increase distance to the source of interference Turn the device to change the angle of radiation Connect the potential equalisation cable Connect the device to a different mains connector Only use original accessories especially patient cables Immediately replace defective cables especially patient cables with defective sheathing Make sure the patient cable is securely screwed on Observe the ma...

Page 56: ...ty High resolution thermal head printer 8 dots mm amplitude axis 20 dots mm time axis 25 mm s Complies with IEC 60601 2 25 and ANSI AAMI EC11 Thermo reactive Z folded 80 mm wide Thermo reactive roll 80 mm wide 5 25 50 mm s for resting ECG 25 50 mm s 5 10 20 mm mV for resting ECG 10 mm mV ECG display Speed Sensitivity ECG is displayed on an area of 108 x 65 mm 5 25 50 mm s 5 10 20 mm mV Interfaces ...

Page 57: ...solated defibrillation protected only with original SCHILLER pa tient cable Lead configurations Standard 12 channels Display Leads Status Display of selected leads 3 x4 Filter status Power source Leads Electrode contact status Heart rate HR Date and time Patient number Filter Myogram filter muscle tremor Notch filter Set to 25 40 150 250 Hz 250 Hz Filter Off Distortion free suppression of superimp...

Page 58: ...afety Standards Safety standard IEC EN 60601 1 IEC EN 60601 2 25 EMC IEC EN 60601 1 2 Protection class Device as a system Class I in accordance with IEC EN 60601 1 Conformity classification CE IIa in accordance with directive 93 42 EEC Protection This device is not designed for outdoor use IP 20 ...

Page 59: ...nd patient cable check 25 Placement 21 Placement with 10 lead patient cable 23 Skin Electrode Resistance 25 Enter the patient data 21 I Isolating from the mains 18 K Keys 14 L Lead sequence 26 M Maintenance 44 Myogram filter 34 N Notch filter 34 O Operation Overview 16 Options 14 P Potential equalisation 17 Power supply 18 R Resting ECG 27 Automatic mode recording 31 Automatic printout 32 Lead gro...

Page 60: ...13 Index Page 60 Art no 2 511235 Rev d CARDIOVIT AT 1 G2 ...

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