AT-102 User Guide Rev N

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: www.schiller.ch Sales information can also be obtained from: [email protected]

Address Headquarters SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland

Article No: 2.510432 rev.: n Issue date: 01.03.10

Tel: +41 (0) 41 766 42 42 Fax: +41 (0) 41 761 08 80 [email protected] www.schiller.ch

AT-102

User Guide

Contents 1

Safety Notes ... 7

1.1

Responsibility of the User ... 7

1.2

Intended Use ... 7

1.3

Organisational Measures ... 8

1.4

Safety-conscious Operation ... 8

1.5

Safety Facilities ... 8

1.6

Operation with other Devices ... 9

1.7

Networks and Internet ... 9

1.8

Maintenance... 10

1.9

Extra Precautions for Spirometry ... 10

1.10

Terms of Warranty... 11

1.11

Safety Symbols and Pictograms ... 12

Art. no.: 2.510432 rev.: n

1.11.1 Symbols Used in this Document ... 12 1.11.2 Symbols Used on the Device ... 13

2

Introduction ... 14

2.1

Features... 14

2.1.1 2.1.2

Standard... 14 Options... 15

2.2

Main Components of the AT-102... 16

2.2.1 2.2.2 2.2.3

Back Panel ... 17 Keypad ... 18 LCD Screen... 20

3

Operation ... 22

3.1

Start-up and Initial Preparation ... 22

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

Location... 22 Connection of External Cable Assemblies and Ancillary Equipment 22 Potential Equalisation... 22 Switching ON and OFF ... 23 Power Supply and Power Supply Indicator ... 23 Recharging the Battery ... 23 Isolating the Mains Supply ... 23 System and ECG Settings ... 23 LCD Contrast Adjustment ... 23

3.2

Changing the Printing Paper ... 24

3.3

Entering Patient Data ... 26

3.3.1 3.3.2 3.3.3 3.3.4

Entering the ECG Acquisition Screens ... 27 Taking a Resting ECG Directly from the Patient Screen... 27 PDQ ... 28 Barcode Reader ... 29

4

Electrode Placement ... 30

4.1

Basics ... 30

4.2

Electrode Identification and Colour Code ... 30

4.3

Standard 10-lead Resting ECG... 31

4.3.1

Placing the Electrodes ... 31

Page 3

Page 4

4.4

Modified Mason - Likar (Exercise ECG)... 32

4.5

Further Lead Combinations... 33

4.5.1 4.5.2

Nehb Leads... 33 Additional Leads ... 34

4.6

Skin/Electrode Resistance... 35

4.6.1

Electrode and Patient Cable Check (Lead Test)... 35

5

Resting ECG ...36

5.1

Automatic Mode Recording ... 37

5.1.1

The Auto Mode Printout ... 38

5.2

Manual Mode (Rhythm Printout) Recording ... 39

5.2.1

The Manual Mode Printout... 39

5.3

Screen (and Manual Printout) Settings... 40

6

Exercise ECG ...42

6.1

Safety Notes ... 42

6.2

General ... 43

6.3

Exercise Flow Diagram ... 44

6.4

Test Procedure Overview... 45

6.5

During the Test ... 47

6.5.1

Entry of Blood Pressure Values ... 48

7

Memory ...49

7.1

Using the Memory... 49

7.1.1 7.1.2

Selecting a Recording... 50 Printing, Deleting and Transmitting Recordings... 50

7.2

Transmit Options ... 51

8

Worklist (Option) ...53

8.1

Opening the Worklist Screen... 54

8.1.1 8.1.2 8.1.3

Receiving a Worklist ... 55 Taking a Worklist Recording ... 55 Sending Worklist Recordings to the HIS... 55

9

Unit and ECG Settings ...56

9.1

Entering the Settings Screens... 56

9.2

ECG Settings... 57

9.2.1 9.2.2 9.2.3 9.2.4 9.2.5

Table of ECG Settings and Options - Auto Format 1 and 2... 57 Filter ... 58 Interpretation... 59 Leads ... 60 General, Storage and Print Settings ... 61

9.3

Exercise Settings... 62

9.3.1 9.3.2 9.3.3

General Settings ... 62 Defining / Editing a Protocol... 64 Factory Preset Protocols... 65

9.4

System Settings... 66

9.4.1 9.4.2 9.4.3

System Settings - Unit ... 66 System Settings - Communication... 68 System Settings - Test and Info... 71

Art. no.: 2.510432 rev.: n

AT-102

AT-102

9.4.4 9.4.5 9.4.6 9.4.7

Test and Info - Print Setup ... 72 Communications Test ... 74 Installing New Software Options (Upgrade)... 74 Default Settings... 75

10

Unit Maintenance ...76

10.1

Visual Inspection ... 76

10.2

Cleaning the Casing and Cable Assemblies ... 77

10.3

Cleaning the Thermal Print Head ... 77

10.4

Battery Maintenance... 78

10.4.1 10.4.2

Charging the battery ... 78 Battery disposal ... 78

10.5

Changing the fuse and mains voltage ... 79

10.5.1 10.5.2 10.5.3

Fuse types ... 79 Changing a fuse... 79 Changing the mains voltage ... 79

10.6

Trouble Shooting ... 80

10.6.1

Trouble Shooting Table... 80

10.7

Inspection and Check List Report... 82

10.7.1 10.7.2

Every Six Months ... 82 Lifed Item Replacement Every 3 - 5 years... 82

11

Technical Data ...83

11.1

System ... 83

11.2

ECG ... 84

11.3

Safety Standards ... 85

11.4

Options ... 85

11.5

Configurations ... 85

11.6

Electromagnetic Radiation ... 86

11.7

Accessories and Disposables ... 87

12

Spirometry ...88

12.1

Intended use... 88

12.2

Introduction... 88

12.3

Pulmonary Test Overview... 89

Page 5

12.4

Preparation... 90

12.5

Changing the Mouthpiece... 91

12.5.1 12.5.2

SP-250 Sensor... 91 SP-260 Sensor... 92

12.6

Unit Calibration ... 93

12.6.1

Calibration Information... 95

12.7

Taking a Spiro Measurement... 96

12.8

Displaying the Results ... 98

12.8.1

Screen Information... 98

12.9

Best and Predicted Values... 100

Art. no.: 2.510432 rev.: n

12.3.1 Forced Vital Capacity (FVC) ... 89 12.3.2 Slow Vital Capacity (SVC) ... 89 12.3.3 Maximum Voluntary Ventilation (MVV) ... 89 12.3.4 Post-Medication Tests ... 89

AT-102

12.9.1 12.9.2

Definition of Best... 100 Predicted Values... 100

12.10 Spiro Settings ... 101 12.10.1 Printout... 102 12.10.2 Device ... 103

13

Spiro Diagnosis ...104

13.1

International ... 104

13.2

American ... 105

13.2.1 Air Obstruction Categories... 105 13.2.2 Chest Restriction Categories ... 106 13.2.3 Ratio of Post (Pre/Post) ... 106

Measured Values ... 107

13.4

Norm Values... 108

13.4.1

Ethnic Influences on Predicted Norm Value ... 108

13.5

International Norm Standards ... 110

13.5.1 13.5.2 13.5.3 13.5.4 13.5.5 13.5.6

ECCS ... 110 Quanjer and Tammeling ... 110 Forche 97 (Austrian Standard)... 111 Swedish Standard (Berglund) ... 112 Finnish Standard... 112 Indian Standard... 113

13.6

Norm Values for the USA and Canada... 114

13.6.1 13.6.2 13.6.3 13.6.4 13.6.5 13.6.6 13.6.7

Morris ... 114 Crapo ... 114 Morris and Crapo Norm Values for Children... 115 Knudson... 116 Knudson 76... 117 Composite Norm Values ... 118 Polgar Norm Values... 118

14

Index ...121

Art. no.: 2.510432 rev.: n

13.3

Page 6

AT-102

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.  The numerical and graphical results and any interpretation given must be examined with respect to the overall clinical condition of the patient and the general recorded data quality.  The indications given by this equipment are not a substitute for regular checking of vital functions.  Specify the competencies of the personnel for operation and repair.  Ensure that personnel have read and understood these operating instructions. In particular this section “safety ‘notes‘ must be read and understood.  Damaged or missing components must be replaced immediately.  The operator is responsible for compliance with all applicable accident prevention regulations and safety regulations.

1.2

Intended Use

Art. no.: 2.510432 rev.: n

 The AT-102 is a 12-channel, ECG device used for the recording, analysis and evaluation of ECG Recordings. Recordings made with the AT-102 can be used as a diagnostic aid for heart function and heart conditions. It is designed for indoor use and can be used for all patients of both sexes, all races, and all ages.  The diagnostic applications for which the AT-102 is intended is in the diagnosis of cardiac abnormalities in the general population, detecting acute miocardial ischemia, and infarction in chest pain patients, etc.  The AT-102 is intended for use in hospitals, cardiological units, out-patient clinical units, and general physicians offices.  The AT-102 includes a low sensitivity setting. Low sensitivity will suppress certain non-specific ECG diagnoses; this can be used for screening high-specificity program intended for low-risk patients. The high sensitivity setting is used for detecting cardiac abnormalities in all and high risk patients including those taking thrombosis medication.  There is no danger for patients with pacemaker.  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. 

© This unit is CF classified and defibrillation protected only when the original

patient cable is used. However, as a safety precaution when possible, remove electrodes before defibrillation.  This product is not designed for internal use. This product is not designed for direct cardiac application.

Page 7

1 1.3

Safety Notes Organisational Measures

1.3

AT-102

Organisational Measures 

  

1.4

Safety-conscious Operation   

 



1.5

Before using the unit, ensure that an introduction regarding the unit functions and the safety precautions has been provided by a medical product representative. Keep these operating instructions in an accessible place for reference when required. 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.

Make sure that the staff have read and understood the operating instructions particularly this “Safety Notes” section. 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.

Safety Facilities 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 cable connections and connectors must be replaced immediately. – The electrical safety devices, such as fuses, must not be altered. – Ruptured fuses must only be replaced with the same type and rating as the original.

Art. no.: 2.510432 rev.: n



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AT-102

User Guide

1.6

Safety Notes Operation with other Devices

1 1.6

Operation with other Devices  Only use 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.  Ancillary equipment connected to any analogue and/or digital interface of the unit 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. Everybody 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.  Any other equipment used with the patient must use the same common earth as the AT-102.  Precautions must be observed when using high frequency devices. Use the special high 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, an electrode becomes displaced, or an electrode resistance is too high, a lead-off indication is displayed in the upper right part of the screen and an acoustic alarm given.  If the device is a part of a medical system, the original SCHILLER patient cable must only be used with, and connected to, the patient connector on the AT-102.  Portable communication devices, HF radios and devices labelled with the symbol (non-ionic electromagnetic radiation) can affect the operation of this device (see page 86).

1.7

Networks and Internet  When the unit is part of a network, (LAN, WLAN, HIS, etc.), transmitting over a telephone network or any other transmission /reception medium, or if exposed to the Internet or other insecure networks, appropriate security measures must be provided to protect the patient data stored.  Patient security and security of the network is the sole responsibility of the user.

Art. no.: 2.510432 rev.: n

 SCHILLER takes no responsibility for the configuration of Windows.

Page 9

1 1.8

Safety Notes Maintenance

AT-102

1.8

Maintenance     

1.9

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 solvent or abrasive cleaners on either the unit or cable assemblies. Do not, under any circumstances, immerse the unit or cable assemblies in liquid.

Extra Precautions for Spirometry 

  

Art. no.: 2.510432 rev.: n



For correct predicted values and diagnosis, it is important that all patient data is entered correctly. In particular gender, date of birth, ethnic, height and weight must be entered. The unit must be calibrated at the beginning of every day, or after a significant change in temperature. False measurements can result when the sensor is not held vertically - always ensure that the sensor is held upright at all times. If using the SP-250 sensor - The disposable mouthpiece of the SP-250 spiro sensor is designed for one-time use to eliminate the danger of cross contamination - do not use the mouthpiece for more than one patient. Do not attempt to clean the mouthpiece. If using the SP-260 sensor - The mouthpiece of the SP-260 spiro sensor is reusable. Thoroughly disinfect the mouthpiece assembly before using for another patient. Replace the filter after every patient - do not use the filter for more than one patient.

Page 10

AT-102

User Guide

1.10

Safety Notes Terms of Warranty

1 1.10

Terms of Warranty The SCHILLER AT-102 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 authorized by him, and • the SCHILLER AT-102 and approved attached equipment is used in accordance with the manufacturers instructions.

Art. no.: 2.510432 rev.: n

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.

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1 Safety Notes 1.11 Safety Symbols and Pictograms

AT-102

1.11

Safety Symbols and Pictograms

1.11.1

Symbols Used in this Document The safety level is classified according ANSI Z535.4. The following overview shows the used safety symbols and pictograms used in this manual.

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 equipment.

Single patient use only - dispose after use, do not reuse.

For general safety notes as listed in this chapter.

Used for electrical dangers, warnings and other notes in regarding operation with electricity. Note For possibly dangerous situations, which could lead to damage to property or system failure. Important or helpful user information.

General symbol indicating non-ionic electromagnetic radiation.

Page 12

Art. no.: 2.510432 rev.: n

Reference to other guidelines.

AT-102

User Guide

1.11.2

Safety Notes Safety Symbols and Pictograms

1 1.11

Symbols Used on the Device Potential equalization

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 Equipment/components and accessories no longer required must be disposed of in a municipally approved collection point or recycling centre. Alternatively, you can return the equipment to your supplier or SCHILLER AG for disposal. Improper disposal can harm the environment and human health.

The unit/component can be recycled.

Notified body of the CE certification (TÜV P.S.).

Attention: Consult accompanying documents.

The following applies to AT-102 units with the SCM module and wireless LAN.

Art. no.: 2.510432 rev.: n

Attention: Non-ionic electromagnetic environment. The device contains an HF transmitter. The AT-102 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-102 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-102. A minimum distance of 20 cm must be kept between the device and a pacemaker. • Turn the device to change the angle of radiation. • Connect the device to a different mains connector. For more details (see page 86).

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2 2.1

Introduction Features

AT-102

2 Introduction 2.1

Features The SCHILLER AT-102 is a 12-channel ECG unit designed to record, display, and measure resting ECGs. The AT-102 has the following features:

2.1.1

Standard

Art. no.: 2.510432 rev.: n

• Alphanumeric keypad and dedicated soft key interface for easy, user friendly operation. • Memory for up to 40 recordings. • Integral full size thermal quality printer with various user defined print format options.

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AT-102

User Guide

2.1.2

Introduction Features

2 2.1

Options • Exercise ECG with interface for control of digital ergometers and treadmills. • External printer. • ECG Interpretation including measurements and average cycles with automatic and manual printout of the recording. • VGA socket for connection of an external monitor (ECG traces only). • Sensor for spirometry recording (software is standard and pre installed on the AT102). Two sensors are available for use with the spiro software: – SP-260 sensor. This sensor has a disposable filter in the mouthpiece. After every patient the filter must be changed and the mouthpiece sterilised. – SP-250 sensor. This sensor has a disposable mouthpiece assembly. For every new patient the mouthpiece assembly is replaced as a complete assembly removing the need to sterilise after every patient. • Worklist - Upload of work list from SEMA200 patient management program. • Barcode Reader - for automatic entry of patient ID or ref. No. • Patient Data Query - upload of patient data from a hospital based data management system (only with SCM).

SCHILLER Communication Module (SCM) Analogue Modem connecter (with optional internal modem). RJ-45 ethernet connector (network). USB connectors. Wireless LAN card.

Art. no.: 2.510432 rev.: n

• • • •

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2 2.2

Introduction Main Components of the AT-102

2.2

AT-102

Main Components of the AT-102

2 1 3

4 5

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.

(1) Keypad and dedicated function keys. (2) LCD Display. (3) Soft-key control Keys (4) RS-232 for any of the following: – connection of an ergo device – connection of a spiro sensor – connection of a modem or a PC for export of stored recordings. (5) Patient cable connector.

Page 16

Art. no.: 2.510432 rev.: n



AT-102

Introduction Main Components of the AT-102

User Guide

2.2.1

1

2

2 2.2

Back Panel

3

4

5

6

7

Connectors (1) and (2) are only available when the SCHILLER Communication Module (SCM) option is installed. (1) RJ-45 Ethernet LAN connector (Local Area Network). a

b

(2) This position has one of the following: – RJ-11 telephone connector (a), (with optional internal modem), or – USB connector (b) for barcode reader. Note that it is not possible to have both an RJ-11 telephone connector and a USB connector on the same unit.

Art. no.: 2.510432 rev.: n

(3) VGA connector for an external monitor (option). (4) LPT connector for an external printer. (5) Master Reset. (6) 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

 If an external printer, monitor or ergo device is connected to the AT-102, the potential equalisation stud must be connected to common ground when the AT-102 is working on battery power i.e. when the mains lead (with grounding lead) is not connected to the unit (see page 22). (7) Mains connector and fuse box (see page 79).

Page 17

2 2.2

Introduction Main Components of the AT-102

2.2.2

AT-102

Keypad

4 5 6 1

7

2 8

(1) The top figures on the number keys and the top line keys from left to right are as follows:

• 1 and 2 (designated < and >), change the lead group displayed on the screen, forward and backward resp. • Auto sensitivity key - automatically sets the ECG printout sensitivity (in auto mode only) to the best setting for the signal strength (5mm/mV or 10mm/mV) • 4, 5 and 6 sets the sensitivity of the ECG both on the screen and on the (manual) printout to 5, 10 or 20 mm / mV, resp. • 7, 8 and 9 sets speed of the ECG both on the screen and on the (manual) printout 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 the same key which toggles the two speeds. • 0- inserts a 1mV reference marker on the screen and printout. Recentres the trace. • QRS beep - toggles the QRS beeper On/Off • Myogram filter On/Off. The cutoff frequency can be user defined in Setup see page 56). • Delete last typed character.

(2) Open / Close

Open close paper tray (to replace thermal printing paper).

(3) Function Key

When pressed before another key, initiates the second function of that key. For example, second letters on the keypad - è, é, ç, ø @ etc., are entered by holding the function key before pressing the letter key.

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Art. no.: 2.510432 rev.: n

3

AT-102

User Guide

Introduction Main Components of the AT-102

2 2.2

(4) Soft-keys

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 soft-key, it has no function for the current screen.

(5) Recording keys

• Auto Key - Auto Mode recording (in Auto mode 1). Press the Shift followed by the Auto key for auto mode 2. • Stop key - stop printout or confirm (new) setting (in a settings screen).

(6) Patient data key

Press this key to enter a new patient or modify the data for the current one. The first screen displayed on initial switch on can be set to the patient data screen, or the ECG screen. This is set for user preference in the system settings (see page 66). The mains indicator is lit when mains power is connected.

(8) Cursor and general arrow keys

Press the function key (3) 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.

Art. no.: 2.510432 rev.: n

(7) On / Off Keys and mains Indicator

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2 2.2

Introduction Main Components of the AT-102

2.2.3

AT-102

LCD Screen 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 soft-key options. The following is an example of a typical resting ECG screen.

1

2

4

3

Art. no.: 2.510432 rev.: n

Items (1) Information bar, and (3) soft-key options, in the same position for all screens.

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