User Guide
72 Pages
Preview
Page 1
AT-101/Tele
Art. no.: 2.510526 Rev.: e *2.510526*
AT-101 12-Channel ECG Unit AT-101 Tele with Telemetric ECG Data Transfer
User Guide
Sales and Service Information The SCHILLER sales and service centre network is world-wide. For the address of your local distributor, contact your nearest SCHILLER subsidiary. In case of difficulty a complete list of all distributors and subsidiaries is provided on our internet site: http://www.schiller.ch.
Sales information can also be obtained from: [email protected]
Address Headquarters SCHILLER AG Altgasse 68 CH-6341 Baar, Switzerland Web:
Article no.: 2.510526 Rev.: e Issue date: 11.04.12
Phone: +41 (0) 41 766 42 42 Fax: +41 (0) 41 761 08 80, E-mail: [email protected] www.schiller.ch
AT-101/Tele
User Guide
Art. no.: 2.510526 Rev.: e
Contents 1
Safety Notes ... 5
1.1
Responsibility of the User ... 5
1.2
Intended Use ... 5
1.3
Organisational Measures ... 6
1.4
Safety-Conscious Operation ... 6
1.5
Safety Facilities ... 6
1.6
Operation with other Devices ... 7
1.7
Maintenance... 7
1.8
Safety Symbols and Pictograms ... 8
1.8.1 1.8.2
Symbols Used in this Document ... 8 Symbols used on the device ... 9
1.9
Terms of Warranty... 10
2
Introduction ... 11
2.1
Features of the AT-101... 11
2.1.1 2.1.2
Standard Features ... 11 Options... 11
2.2
Features of the AT-101 Tele... 11
2.2.1
Options... 11
2.3
Operation – Overview... 12
2.3.1 2.3.2 2.3.3 2.3.4
Functions... 12 Main Components of the AT-101 ... 13 Back Panel of the AT-101 ... 13 Back Panel of the AT-101 Tele ... 14
2.4
Keypad... 15
2.5
AT-101 Display... 17
2.6
AT-101 Tele Display... 18
3
Operation ... 19
3.1
Start-up and Initial Preparation ... 19
3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6 3.1.7 3.1.8 3.1.9
Connecting and Power on... 19 Battery operation... 20 Switching on and off... 20 Isolating the device from the mains supply ... 20 Potential equalisation ... 20 Inserting printing paper ... 21 LCD contrast adjustment... 22 Inserting the SIM Card for AT-101 Tele ... 22 Mounting the Antenna for AT-101 Tele ... 22
3.2
Entering Patient Data ... 23
4
Resting ECG ... 24
4.1
Electrode Placement ... 24
4.2
Further Lead Combinations... 26
4.2.1 4.2.2
Nehb Leads... 26 Electrode Positions for Additional Leads... 27
Page 1
Page 2
4.2.3
Electrode identification and colour code ... 28
4.3
Skin/Electrode Resistance... 29
4.3.1 4.3.2
High electrode resistance indication ... 29 Electrode and patient cable check (lead test) ... 29
4.4
Procedural Flow Diagram ... 30
4.4.1 4.4.2 4.4.3 4.4.4
Automatic mode recording ... 31 Automatic printout or transfer of the ECG data... 32 Manual mode ... 33 Screen (and manual printout) settings ... 34
4.5
Memory ... 36
4.5.1 4.5.2
Transmitting recordings from the memory ... 37 Automatic ECG data transmission ... 39
5
Setup ...40
5.1
Entering the Setup Menu ... 40
5.1.1
Navigating in the setup screens... 40
5.2
ECG Settings... 41
5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6
Automatic formats 1 and 2, internal printer ... 42 Automatic formats 1 and 2, external printer ... 43 Filters ... 44 Interpretation (only with version C) ... 45 Leads ... 46 General ... 47
5.3
System Settings... 48
5.3.1 5.3.2 5.3.3 5.3.4 5.3.5 5.3.5.1 5.3.5.2 5.3.5.3 5.3.5.4 5.3.5.5
Unit... 49 Communication (RS-232) ... 50 Communication with SCM... 51 Country ID... 52 Test and information ... 53 Print setup... 54 Communication test ... 55 Installing new software options (upgrade) ... 55 Updating the software ... 55 Default settings ... 56
6
Maintenance ...57
6.1
Maintenance Interval ... 57
6.2
Communication (RS-232) Test... 57
6.3
Maintenance Interval for the Battery... 58
6.3.1 6.3.2
Charging the battery ... 58 Battery disposal ... 58
6.4
Changing the Fuse and Mains Voltage... 59
6.5
Cleaning... 60
6.5.1 6.5.2 6.5.3
Cleaning the casing ... 60 Cleaning the patient cable ... 60 Cleaning the thermal print head... 60
6.6
Inserting Printing Paper ... 61
6.6.1
Thermal paper handling ... 61
6.7
Fault-Finding ... 62
6.7.1 6.7.2
Measures to prevent electromagnetic interferences ... 64 Accessories and disposables... 65
7
Technical Data ...66
Art. no.: 2.510526 Rev.: e
AT-101/Tele
User Guide
7.1
System... 66
7.2
Technical Data for ECG... 67
7.3
Safety Standards ... 68
7.4
GSM Telecommunication with AT-101 Tele ... 68
8
Index ... 69
Art. no.: 2.510526 Rev.: e
AT-101/Tele
Page 3
Art. no.: 2.510526 Rev.: e
AT-101/Tele
Page 4
AT-101/Tele
User Guide
Safety Notes Responsibility of the User
1 1.1
1 Safety Notes 1.1
Responsibility of the User This device must only be used by qualified doctors or trained medical personnel under their direct supervision. The numerical and graphical results as well as any interpretation suggested by the device must be examined with respect to the patient's overall clinical condition and the quality of the recorded data. The responsibilities of the personnel for the operation and maintenance of the device must be specified. Ensure that the personnel have read and understood this user guide. In particular this section “safety notes" must be read and understood. Damaged or missing components must be replaced immediately. It is the owner's responsibility that the valid regulations for safety and prevention of accidents are observed.
1.2
Intended Use The AT-101 is a 12-channel ECG device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-101 can be used as a diagnostic aid for heart function and heart conditions. The device is designed for indoor use and can be used for all patients of both sexes, all races, and all ages. In addition, the AT-101 Tele can transmit saved ECG recordings via GSM at 850/ 900/1800/1900 MHz. There is no danger when using the device for a patient with a pacemaker fitted. To prevent a pacemaker malfunction, a distance of at least 20 cm must be kept between the antenna of the AT-101 Tele and the pacemaker as soon as the GSM module is switched on. Only operate the device in accordance with the specified technical data. The device is not designed for sterile use nor is it designed for outdoor use. Do not use this unit in areas where there is any danger of explosion or in the presence of flammable gases such as anaesthetic agents.
Art. no.: 2.510526 Rev.: e
© The device is CF classified. It is defibrillation protected when the original
SCHILLER patient cable is used. However, as a safety precaution when possible, remove the electrodes before defibrillation. This product is not designed for internal use. This product is not designed for direct cardiac application.
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Safety Notes Organisational Measures
1.3
AT-101/Tele
Organisational Measures
1.4
Safety-Conscious Operation
1.5
This user guide, and especially these safety notes, must be read and observed. Do not touch the unit casing during defibrillation. To ensure patient safety, none of the electrodes including the neutral electrode, nor the patient or any person with simultaneous patient contact, must come in contact with conductive parts, even when these are earthed. Immediately report any changes that impair safety (including operating behaviour) to the person responsible. Do not place any liquids on the unit. If liquid should be spilled over the device, immediately disconnect the device from the mains and wipe it. The device must be serviced before reusing. Only connect the original SCHILLER patient cable to the patient socket. As soon as the GSM module is switched on, all persons must keep a distance of at least 20 cm from the sending antenna of the AT-101 Tele. The transmission of ECG recordings from the AT-101 Tele is not permitted in areas in which handies are not allowed.
Safety Facilities
Page 6
Before using the unit, ensure that an introduction regarding the unit functions and the safety precautions has been provided by a medical product representative. Always store the user guide handy near the device. Make sure that they are always complete and legible. Observe the operating instructions and maintenance instructions. These operating instructions do not override any statutory or local regulations, or procedures for the prevention of accidents and environmental protection.
Operating the device without the correctly rated fuse, or with defective cables, constitutes a danger to life. Therefore: – Do not operate the unit if the earth connection is suspect or if the mains lead is damaged or suspected of being damaged. – Damaged cables and connections must immediately be replaced. – The electrical safety devices, such as fuses, must not be modified. – Ruptured fuses must only be replaced with the same type and rating as the original. – Immediately replace the defective antenna of the AT-101 Tele. Only use antennas approved by SCHILLER AG.
Art. no.: 2.510526 Rev.: e
1 1.3
AT-101/Tele
Safety Notes Operation with other Devices
User Guide
1.6
1 1.6
Operation with other Devices
Use only accessories and other parts recommended or supplied by SCHILLER AG. Use of other than recommended or supplied parts may result in injury, inaccurate information and/or damage to the unit. Accessory equipment connected to the analogue and digital interfaces must be certified according to the respective IEC standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC/ EN 60601-1-1. Everyone who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult the technical service department or your local representative. – EC/EN 60601-1-1 states that the patient must remain at least 1.5 meters clear of the unit. If this is not possible, a safety isolating transformer must be installed. Any other equipment used with the patient must use the same common earth as the AT-101/Tele. Precautions must be observed when using high frequency devices. Use the frequency SCHILLER patient cable to avoid possible signal interference during ECG acquisition. There is no danger when using the ECG unit simultaneously with electrical stimulation equipment. However, the stimulation units should only be used at a sufficient distance from the electrodes. If in doubt, the patient should be disconnected from the device. If the patient cable should become defective after defibrillation, a lead-off indication is displayed on the screen and an audible alarm issued. If the device is part of a medical system, the original SCHILLER patient cable must only be used with, and connected to, the patient connector on the AT-101/ Tele. Portable communication equipment, HF two-way radios and devices marked with the
Art. no.: 2.510526 Rev.: e
1.7
symbol can affect this unit. (See section 6.7.1.)
Maintenance
Danger of electric shock! Do not open the device. No serviceable parts inside. Refer servicing to qualified technician authorised by SCHILLER only. Before cleaning and to isolate the mains power supply, switch the unit off and disconnect it from the mains by removing the plug. Do not use high temperature sterilisation processes (such as autoclaving). Do not use E-beam or gamma radiation sterilisation. Do not use aggressive or abrasive cleaners. Do not, under any circumstances, immerse the unit or cable assemblies in liquid.
Page 7
1 1.8
Safety Notes Safety Symbols and Pictograms
AT-101/Tele
1.8
Safety Symbols and Pictograms
1.8.1
Symbols Used in this Document The safety level is classified according ANSI Z535.4. The following overview shows the safety symbols and pictograms used in this user guide. For a direct danger which could lead to severe personal injury or to death.
For a possibly dangerous situation, which could lead to serious bodily injury or to death.
For a possibly dangerous situation which could lead to personal injury. This symbol is also used to indicate possible damage to property.
For general safety notes as listed in this section.
Used for electrical dangers, warnings and other notes in regarding operation with electricity. Reference to other user guides.
Art. no.: 2.510526 Rev.: e
Note For possibly dangerous situations, which could lead to damages to property or system failure. Important or helpful user information
Page 8
AT-101/Tele
User Guide
1.8.2
Safety Notes Safety Symbols and Pictograms
1 1.8
Symbols used on the device Potential equalisation CF symbol. This unit is classified safe for internal and external use. However, it is only defibrillation protected when used with the original SCHILLER patient cable! Symbol for the recognition of electrical and electronic equipment. This unit must be disposed of in a municipally approved collection point or recycling centre. Improper disposal harms the environment and human health due to the presence of dangerous substances in electrical and electronic equipment. The unit/component can be recycled.
Notified body of the CE certification (TÜV P.S.).
Note accompanying documents! On AT-101 Tele only Attention: Non-ionic electromagnetic environment. The device contains an HF transmitter.
Art. no.: 2.510526 Rev.: e
The AT-101 Tele radiates radio frequency transmitting electromagnetic energy during telemetric ECG data transfer and can disturb other devices if not installed and operated in accordance with the user guide. However, there is no guarantee that no interference can occur in certain installations. If the AT-101 Tele causes interferences, these can be determined by switching the device off/on or by transmitting/not transmitting ECG data. The user can take the following measures to solve this problem: • Increase the distance between the disturbed device and the AT-101 Tele. A minimum distance of 20 cm must be kept between the device and a pacemaker. • Turn the device to change the antenna's angle of radiation. • Connect the device to a different mains connector. For more details refer to section 6.7.1 on page 64.
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1 1.9
Safety Notes Terms of Warranty
AT-101/Tele
1.9
Terms of Warranty The SCHILLER AT-101 is warranted against defects in material and manufacture for the duration of one year (as from date of purchase). Excluded from this guarantee is damage caused by an accident or as a result of improper handling. The warranty entitles free replacement of the defective part. Any liability for subsequent damage is excluded. The warranty is void if unauthorised or unqualified persons attempt to make repairs. In case of a defect, send the apparatus to your dealer 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 carried out by persons authorised by him, and • the SCHILLER AT-101 and approved attached equipment is used in accordance with the manufacturer’s instructions. There are no express or implied warranties which extend beyond the warranties hereinabove set forth. SCHILLER makes no warranty of merchantability or fitness for a particular purpose with respect to the product or parts thereof.
Art. no.: 2.510526 Rev.: e
This equipment has been tested and found to comply with the limits for a class A digital device, pursuant to both Part 15 of the FCC (Federal Communications Commission) rules and the radio interference regulations of the Canadian Department of Communications. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with this instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.
Page 10
AT-101/Tele
User Guide
Introduction Features of the AT-101
2 2.1
2 Introduction 2.1
Features of the AT-101 The SCHILLER AT-101 is a 12-channel ECG unit designed to record, display, and analyse resting ECGs. The unit has been extensively researched to give an ergonomic, clear interface that‘s easy to use without compromising functionality. The AT-101 has the following features:
2.1.1
Standard Features • Alphanumeric keypad and dedicated soft key interface for easy, user friendly operation • Integral full size thermal quality printer with various user defined print format options • Measurements and average cycles with automatic and manual printout of the recording
2.1.2
Options • • • • •
2.2
External printer ECG interpretation Memory for up to 40 recordings Thrombolysis SCHILLER Communication Module (SCM) for data transmission to server via: – Ethernet – Modem (option)
Features of the AT-101 Tele • In addition to the features of the AT-101, the AT-101 Tele contains mobile telemetric ECG data transfer • World-wide with quad-band GSM 850/900/1800/1900 MHz • The standard equipment also includes a memory for up to 40 recordings and the SCHILLER Communication Module (SCM) for data transfer to a server via Ethernet or a modem
Art. no.: 2.510526 Rev.: e
2.2.1
Options • External printer • ECG interpretation • Thrombolysis
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2 2.3
Introduction Operation – Overview
AT-101/Tele
2.3
Operation – Overview There are broadly four types of data display as follows:
Data acquisition and ECG recording screen
In this screen the real-time ECG is displayed. From this screen a continuous printout can be initiated and/or an auto recording can be made. In auto mode 10 seconds of ECG data is analysed and averaged and the results given on a printout. The format and data of an auto mode printout is independent of the screen display, and is defined in the setup screens. (See paragraph 5.2 page 41). An auto mode recording can also be stored in the memory for later print or transmission.
Memory
In this screen, stored recordings can be accessed, printed and transmitted.
Patient data
Patient data entry via the keypad.
Data entry and setup
In these screens all system settings are made.
2.3.1
Functions Most functions and tasks are initiated by the 5 softkeys (1) situated immediately below the LCD. The function of the softkeys varies according to the screen displayed and is displayed on the LCD immediately above the key itself. During data acquisition, further dedicated function keys are provided to make an auto mode recording (START) and to stop a manual printout (STOP). The top line of the alphanumeric keypad additionally enables direct settings of lead group, trace speed and sensitivity, filter on/off and other functions, for both the real-time display and (manual) printout.
HR: 78/min
FILTER OFF
1
Fig. 2.1 Welcome page
Page 12
MANUAL PRINT
MENU
Art. no.: 2.510526 Rev.: e
LEAD TEST
AT-101/Tele
Introduction Operation – Overview
User Guide
2.3.2
2 2.3
Main Components of the AT-101 (1) LCD screen (2) Function keys (3) Keypad and dedicated function keys (4) Printer
1
2
3
4
2.3.3
Back Panel of the AT-101
Art. no.: 2.510526 Rev.: e
All externally connected hardware must be approved by SCHILLER. Connection of any hardware not approved by SCHILLER is at the owner‘s risk. The unit guarantee may also be invalid. See also safety note paragraph 1.6. (1) Patient cable connector (2) LPT connector for an external printer (3) RS-232 for connection of a modem or a PC for export of stored recordings (4) Mains connector (with fuse above) (5) RJ11 modem connector with SCM (option) (6) Potential equalisation stud (7) RJ45 connector for Ethernet with SCM (option)
2 3 1 4 5 6 7
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2 2.3
Introduction Operation – Overview
AT-101/Tele
2.3.4
Back Panel of the AT-101 Tele (1) SIM card (2) RJ45 connector for Ethernet with SCM (3) Antenna (4) RJ11 modem connector with SCM (not visible)
1
3
Art. no.: 2.510526 Rev.: e
2
4
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AT-101/Tele
Introduction Keypad
User Guide
2.4
2 2.4
Keypad HR: 78/min
FILTER OFF
LEAD TEST
1
MANUAL PRINT
2
MENU
3
Art. no.: 2.510526 Rev.: e
(1) Softkeys - the function of these keys changes depending on the screen displayed. The function of these keys is shown on the screen above the keys. If nothing is written above a softkey, it has no function for the current screen. (2) Auto Mode recording (in Auto mode 1). Press the SHIFT followed by the START key (2) for auto mode 2. (3) STOP printout
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2 2.4
Introduction Keypad
4
17
AT-101/Tele
5
6
7
8
9
10
16
11
12
13
15
14
(4) The top figures on the number keys 1 and 2 (designated < and >) change the lead group displayed on the screen forward and backward, respectively. (5) Auto sensitivity key – automatically sets the ECG printout sensitivity (in auto mode only) to the best setting for the signal strength (5 mm/mV or 10 mm/mV). (6) The top figures on the number keys designated 5, 10, and 20 set the sensitivity of the ECG both on the screen and on the (manual) printout. Sensitivity – 5, 10 or 20 mm/mV. (7) The top figures on the number keys designated 5/10, 25, and 50 set the speed of the ECG both on the screen and on the (manual) printout. The speed on the screen can only be set to 25 or 50 mm/s. The speed of the manual printout can be 5, 10, 25 or 50 mm/s. The 5 and 10 mm/s settings are both on key 7, which toggles the two speeds. (8) Inserts a 1 mV reference marker on the screen and printout. Recentres the trace. (9) Toggles the QRS beeper on/off. (10) Switches the myogram filter on or off. The cutoff frequency can be user defined in ‘Setup‘. (11) Delete last typed character. (12) Patient data key: Press this key to enter a new patient or modify the data for the current one.
(13) ON/OFF key (14) Mains indicator – lit when mains connected. (15) Press the function key (16) and the UP/DOWN arrows to adjust screen contrast. When entering patient data, use the LEFT/RIGHT arrow keys to move the cursor in the data field. Use the UP/DOWN arrow keys to go up/down to the next data entry. (16) Shift key for capital letters and, in AT-101 Tele, GSM switch on/off (see page 51). (17) When pressed before another key, initiates the second function of that key. For example, second letters on the keypad – é, è, ç, Ø, ›, @ etc. – are entered by holding the function key before pressing the letter key.
Page 16
Art. no.: 2.510526 Rev.: e
The patient data screen, or the ECG screen is the first screen displayed on initial switch on. This is set for user preference in the menu SYSTEM SETTINGS/UNIT. (See page 49.)
AT-101/Tele
Introduction AT-101 Display
User Guide
2.5
2 2.5
AT-101 Display The display will vary according to the current task being carried out. In all screens however, the top and bottom lines always display the same information: the top line displays system information, and the bottom line displays the softkey options. The following is an example of a typical resting ECG screen.
~
1 HR: 78/min
4 5
2
6 7 FILTER OFF
8 9 10
3
LEAD TEST
MANUAL PRINT
MENU
Items 1, 2 and 3 are in the same position for all screens. (1) Top line – time, date, patient name, and current power source – mains (~), or battery ( ). When battery capacity is limited the battery symbol flashes. (2) Data acquisition area or data entry area. (3) Softkey designation. Pressing the key below the text carries out the function indicated. The options available will change according to the screen displayed.
Art. no.: 2.510526 Rev.: e
Items 4 to 10 are specific for ECG acquisition only: (4) Current heart rate (averaged over 4 beats and refreshed every 2 seconds). The HR is also given on a manual printout. Note that with an auto mode printout the HR is averaged over the full 10 seconds of the recording. (5) Electrode connections - when an electrode indication flashes (an audible alarm is also given), it indicates that the electrode resistance is too high. The electrode(s) must be re-applied. (6) Sensitivity – 5, 10 or 20 mm/mV. Change the sensitivity with the keys 3 (auto), 4, 5 and 6. An "A" in this box indicates that automatic sensitivity is selected (auto mode printout only). (7) Speed – 25 or 50 mm/s. The speed is changed using the keys 8 and 9. (8) Lead indication (leads currently displayed on the screen). Change the lead group with the < and > keys on the keypad. (9) 1Myogram filter indication – FILTER ON or FILTER OFF. The filter is applied with the filter key. (10) Area for system messages or instructions.
1.The definition of filter cutoff frequency is detailed on page 44 ("Filters").
Page 17
2 2.6
Introduction AT-101 Tele Display
AT-101/Tele
2.6
AT-101 Tele Display In addition, the top line of the AT-101 Tele shows the symbols for mobile radio transmission and in the memory screen, you can select the ECG recordings for transmission. 2
1
3
4
5
Switching GSM-Module ON
8
CONNECTING GSM ON
ENTER
SELECT
6
7
TRANSMIT
DELETE
BACK
8
(1) Found provider. , the module is off.
(3) Indication of strength of reception of the GSM network. The strength of reception is not indicated in the automatic mode (see page 47). In this case, you can use your personal mobile phone to check the availability of the transmitting/receiving station. (4) Diagnosis symbol. Indication of the communication between the device and the GSM module. (5) Messages of the GSM module. (6) Manual switch on and off of the GSM module using the function key. (See page 47.) (7) Press ENTER to display the TRANSMIT key. By pressing the TRANSMIT key, the selected ECG is transmitted. (8) Status of the connection to the GSM.
Page 18
Art. no.: 2.510526 Rev.: e
(2) GSM module on. If the symbol is inverted