Quark b2 User manual XVIII Edition May 2008

Table of contents Getting started

12

Important notices ... 13

Intended use ... 13 Warnings ... 13 Contraindication ... 15

Contraindications for the Spirometer tests ... 15 Absolute contraindications... 15 Relative contraindications... 15 Contraindications for Bronchial provocation tests ... 15 Absolute contraindications... 15 Relative contraindications... 15 Contraindications for Exercise testing ... 15 Environmental condition of use ... 16 EMC ... 17 Safety and conformity ... 20

Safety ... 20 EMC ... 20 Quality Assurance ... 20 Medical Device Directive (CE mark) ... 20 Keynotes ... 21

Typographic keynotes ... 21 Graphic keynotes... 21 System overview ... 22

Main features... 22 Flowmeter ... 22 Gas analysers... 22 Environmental conditions measurements... 22 Before starting ... 23

Checking the packing contents... 23 Quark b2 standard packaging ... 23 Warranty registration ... 24

Register the product via software ... 24 How to contact COSMED ... 24 Complain, feedback and suggestions ... 24 Options/Accessories ... 25 PC configuration required ... 26 Technical features ... 27

Flowmeter ... 27 Oxygen Sensor (O2) ... 27 Carbon Dioxide Sensor (CO2) ... 27 Humidity absorber ... 27 Power Supply ... 27 2 - Quark b2 User Manual

Environmental Sensors ... 27 Dimension and Weight ... 27 Aux inputs... 27

Measurements

28

Pulmonary function tests and measured parameters ...29

Breath by Breath exercise testing... 29 Indirect Calorimetry ... 29 Lactate Threshold (V-Slope) ... 29 O2 Kinetics ... 30 Spirometry Tests (option) ... 30 FVC - Forced Vital Capacity ... 30 VC/IVC - Slow Vital Capacity and Ventilatory pattern 30 MVV - Maximum Voluntary Ventilation ... 31 Bronchoprovocation Response ... 31

Installation

32 Unpacking the system ...33 Setting up the system ...34

Calibration Gas Cylinder ... 34 Gas pressure adjustment procedure... 34 Connecting cables and tubing...35

Cables and Tubing installation sequence ... 36 Assemble the turbine ...37

Assemble the mask and the flowmeter ... 37 Using the "Ultimate Seal" ... 37 Apply the seal to the mask ... 38 To remove seal on mask ... 38 Assembling the flowmeter for spirometry tests ... 38 Cardiac Output Module... 39 Connecting PC ... 39 Software installation ...40

Installing the software ... 40 Run the software ... 40 PC port configuration ... 40 Software main features ...41

Display ... 41 Tool bar ... 41 Show/hide the toolbar ... 41 Dialog windows ... 41 Use of the keyboard ... 41 Use of the mouse ... 41 Scroll bars ... 41 On line help ... 41 Software version ... 41

Calibration

42 Chapter 11 - Appendix - 3

Calibrating sensors ... 43

Running the Calibration program... 43 Log file ... 43 Setting reference values ... 43 To set the reference values ... 43 Calibrating analysers ... 44 Print the calibration report ... 44 Edit the calibration factors ... 44 Turbine calibration ... 45

The calibration syringe ... 45 Turbine calibration for ergospirometry tests ... 45 Assembling the flowmeter ... 45 Calibrating the turbine ... 46 Turbine calibration for the RMR test ... 47 Assembling the flowmeter ... 47 Calibrate the turbine... 47 Checking the system signals ... 48

The control panel ... 48 Using the control panel ... 48

Database Management

50

Exercise testing patient's database ... 51

Enter a new patient ... 51 Find a patient ... 51 Edit patient data ... 51 Delete a patient... 51 Archive maintenance ... 52

Reorganise the archive ... 52 Delete the archive... 52 Delete a test ... 52 Backup and restore ... 52 Backup ... 52 Restore ... 52 Spirometry patient's database... 53

Patient Card... 53 Visit Card ... 53 Test Card ... 54 Import/export a Tests card ... 54 Diagnosis Database ... 54 Spirometry program settings ... 55

Graphs ... 55 Serial port... 55 Units of measurements... 55 Using extra fields ... 55 Customise the fields ... 55

Exercise testing 4 - Quark b2 User Manual

56

Recommendations for the exercise testing ...57

The evaluation of the cardiorespiratory function ... 57 Precautions ... 57 Laboratory ... 57 Ending the test ... 57 Preparing the patient ... 57 Before testing ... 57 Patient assent ... 58 Ending the test ... 58 Start Testing ...59

Start a test ... 59 Abort the test without saving data ... 59 End the test saving data ... 59 View data in real-time ... 59 View graphs in real-time ... 60 Parameters to view ... 60 Manual protocol ... 60 Enter Load and Phase ... 60 Set the markers ... 60 Automatic protocol ... 60 Modify the load during the test ... 60 Set the BPM alarm ... 60 Enter the BPM ... 60 Data management ...61

Viewing data ... 61 View data in table form ... 61 Creating graphs ... 61 View data in graph form ... 61 Customise the graphs ... 62 Switch from graph to data and vice versa ... 62 Viewing predicted values ... 63 View predicted values... 63 Anaerobic (Lactate) Threshold detection ... 63 View the Lactate Threshold ... 63 Detect the Lactate Threshold ... 63 Customise graphs for the LT viewing... 63 Fittings ... 64 Fit a graph with a linear regression ... 64 Fit a graph with a Mono-exponential regression ... 64 Calculate the "Mean Value" ... 65 Oxygen Kinetic ... 65 Run the O2 Kinetic function ... 65 Information about the Test ... 66 View the Information ... 66 Modify the information... 66 Summary ... 66 Chapter 11 - Appendix - 5

View the summary ... 66 Print the data ... 66 Print the current window... 67 Print the report ... 67 View the report... 67 Data Editing ... 68

Editing values and input numerical values ... 68 Data filtering ... 68 Using the User fields... 69 Deleting steps ... 69 Advanced Editing ... 69 Restore the original test ... 70 Overwrite the original test ... 70 Customise the desktop... 70 Customise the display colours ... 70 Smart edit ... 70 Apply the graphical noise suppression ... 70 Apply the threshold noise suppression ... 70 Customise the parameters ... 71 Create a new parameter... 71 Create a new predicted parameter ... 71 Exporting data ... 72 Export a test ... 72 DDE with Excel ... 72 Creating Test Protocols ... 73

Create a new protocol ... 73 Software configuration ... 74

Data viewing ... 74 Select the parameters to view ... 74 Select the parameters to view during the test... 74 Sort the parameters ... 74 Steady State ... 74 Customise the Steady State detection criteria ... 74 Printout reports... 75

Set up the printout ... 75 Select parameters to be printed ... 75 Customise the printout header ... 75 Electronic reports (*.pdf) ... 76 Print the current window ... 76 Print the customised report... 76 Events management during exercise testing ... 77

Cardiac Output (option) ... 77 Setting up the Quark b2 for the cardiac output ... 77 Performing a Cardiac Output test ... 78 Flow Volume loops ... 78 Flow Volume loop during the test ... 78 6 - Quark b2 User Manual

O2, CO2 vs Time ... 79 O2, CO2 vs Time during the test ... 79 O2 Saturation (optional) ... 79 O2 Saturation during the test ... 79 Spirogram... 79 Spirogram during the test... 79 View the events after the test ... 80 Raw data... 80 Save Raw data... 80

Resting Metabolic Rate Test

82

Metabolism ...83

Total Metabolic Rate... 83 Resting Metabolic Rate (RMR) ... 83 Importance to measure RMR ... 83 Measure of the rest metabolic rate with indirect calorimetry... 83 How to perform a RMR test... 83 Recommendations ...84

Resting metabolic rate test using the face mask... 84 Resting metabolic rate test using the canopy option ... 84 Performing a test using the face mask ...85

Calibrations ... 85 How to prepare a patient ... 85 Start the test... 85 Viewing the test ... 87 How to modify the average interval ... 87 Print ... 88 Performing a test using the canopy option...89

Calibrations ... 89 How to prepare the canopy and the patient ... 89 Replacement of the power plug ... 89 Connecting the Canopy... 89 How to prepare the patient ... 90 Performing the test ... 90 Viewing the test ... 91 How to modify the average interval ... 91 Print ... 91

Sub-maximal Exercise Testing

92

Introduction ...93

Pre-test screening ... 93 Sub-maximal exercise testing ...94

Considerations with sub-maximal exercise testing ... 94 Staffing... 95 Test termination ... 95 Considerations for accuracy ...96 Performing the test ...97 Chapter 11 - Appendix - 7

An example of testing protocol ... 97

The mixing chamber

98

The mixing chamber ... 99

Overview ... 99 Preparing the mixing chamber for a test ... 99 Two-way non rebreathing valve description ... 99 Patient’s preparation... 100 Performing the test ... 100

Spirometry

102 Setting spirometry options... 103

Spirometry ... 103 Automatic Interpretation ... 103 Quality control ... 103 Parameters manager ... 104 Predicted values manager ... 104 Predicteds set ... 104 Set the current predicted ... 105 Formula definition ... 105 Page set-up ... 106 Spirometry tests ... 107 Forced Vital Capacity (pre) ... 108

Recommendations ... 108 Perform a FVC (pre) test ... 108 Test encouragement ... 108 Perform the FVC test with the encouragement ... 109 Slow Vital Capacity ... 110

Perform a SVC test ... 110 Maximum Voluntary Ventilation ... 111

Perform a MVV test ... 111 Bronchial Provocation Test ... 112

Bronchodilator test ... 112 Methacholine and Histamine Bronchial provocation Tests ... 112 Perform the test ... 113 Bronchial Provocation protocols Database ... 113 Enter a new Bronchial provocation protocol in the archive... 113 Viewing results ... 114

Tests of the current patient... 114 Delete a test ... 114 Printing results... 115

Printing Reports ... 115 Printing the active window... 115 To print the active window ... 115 Printing a series of reports... 115 Electronic reports (*.pdf) ... 115 8 - Quark b2 User Manual

Export data ... 116 Export a test ... 116

System maintenance

118

System maintenance ...119

Cleaning and disinfection ... 119 Preparing the disinfecting solution ... 119 Cleaning the turbine flowmeter... 120 Precautions during the cleaning of the turbine ... 120 Masks cleaning and disinfection ... 120 Disassembling the different parts of the mask ... 120 Cleaning the mask... 120 Disinfecting the mask ... 120 Canopy bubblehood (option) cleaning ... 121 RMR reader (option) cleaning ... 121 Precautions during the cleaning of the turbine ... 121 Two-way non rebreathing valve cleaning (option) ... 121 Mixing chamber cleaning and disinfection (option) ... 121 Permapure maintenance ... 121 Inspections ... 122 Replace the fuses... 122 Select the proper power supply voltage ... 123

Appendix

124 Conformity declaration...125 Service - Warranty ...126

Warranty and limitation of liability ... 126 Return goods policy for warranty or non warranty repair... 126 Repair Service Policy ... 127 Privacy Information ...128

Personal data treatment and purposes ... 128 How your personal data are treated... 128 The consent is optional, but… ... 128 Holder of the treatment ... 128 Customer rights ... 128 Waste of electrical and electronic equipment ...129 Analog - Digital auxiliary inputs...130

AUX RS232 ... 130 Pin-out assignment... 130 Handshaking protocol configuration ... 130 AUX1/ AUX4 analog Inputs... 130 Enable the AUX input ... 130 Converting factors configuration ...132

Pin-out assignment... 132 Heart Rate – TTL input ...133 Calculations references ...134 Chapter 11 - Appendix - 9

VO2 and VCO2 ... 134 Anaerobic threshold (modified V-Slope) ... 134 O2 kinetics ... 134 Cardiac Output ... 134 ATS 94 recommendations ... 135

ATS recommendations ... 135 Predicted values ... 136

Automatic diagnosis (algorithm)... 137 Quality Control Messages ... 137 References... 139

Gas Exchange References ... 139 Indirect calorimetry... 139 Cardiac Output ... 139 Spirometry ... 139 Sub-maximal testing ... 139

10 - Quark b2 User Manual

Chapter 11 - Appendix - 11

Important notices Intended use Quark b2 is an electrical medical device designed to perform pulmonary function tests. It is to be used by physicians or by trained personnel on a physician responsibility. Caution: Federal law restricts this device to sale by or on the order of a physician. This equipment has been conceived with the aim of providing an auxiliary instrument allowing: •

the formulation of lung pathology diagnosis;

•

important studies concerning human physiology;

• the collection of important information in sport medicine. No responsibility attaches COSMED Srl for any accident happened after a wrong use of the device, such as: •

use by non qualified people;

•

non respect of the device intended use;

•

non respect of the hereunder reported precautions and instructions.

Warnings The device, the programme algorithms and the presentation of measured data have been developed according to the specifications of ATS (American Thoracic Society) and ERS (European Respiratory Society). Other international references have been followed when these were not available. All bibliography references are reported in Appendix. The present handbook has been developed with respect of the European Medical Device Directive requirements which sort Quark b2 within Class II a. It is recommended to read carefully the following precautions before putting the device into operation. The precautions reported below are of fundamental importance to assure the safety of all COSMED equipment users. 1. This user manual is to be considered as a part of the medical device and should always be kept on hand. 2. Safety, measure accuracy and precision can be assured only: • using the accessories described in the manual or given with the device. Actually non recommended accessories can affect safety unfavourable. Before using non recommended accessories it is necessary to get in touch with the manufacturer; • ordinary equipment maintenance, inspections, disinfection and cleaning are performed in the way and with the frequency described; • any modification or fixing is carried out by qualified personnel;

3. 4. 5.

6.

• the environmental conditions and the electrical plants where the device operates are in compliance with the specifications of the manual and the present regulations concerning electrical plants. In particular grounding reliability and leakage current suppression can only be assured when the device three – wire receptacle is connected to a yellow - green return connected to earth ground. Attempting to defeat the proper connection of the ground wire is dangerous for users and equipment. Before powering the system, check the power cables and the plugs. Damaged electrical parts must be replaced immediately by authorised personnel. Large gas cylinders, which may be given by the manufacturer or purchased by the customer, should be secured with cylinder safety chains or safety stands. When removing the protective cap, inspect the cylinder valve for damaged threads, dirt, oil or grease. Remove any dust or dirt with a clean cloth. If oil or grease is present on the valve of a cylinder which contains oxygen, do not attempt to use. Such combustible substances in contact with oxygen are explosive. Be certain that the materials of the pressure regulators are chemically compatible with the intended gas service before installation. Inspect the regulator for the proper Chapter 1 - Getting started - 13

connection and note the ranges of the pressure gauges. Also examine the physical condition of the regulator including threads and fittings. Remove any dust or dirt from the regulator or cylinder valve with a clean cloth. Do not install a regulator on a cylinder valve containing oxygen if grease or oil is present on either. Such substances in contact with oxygen are explosive. 7. Cleaning residue, particulates, and other contaminates (including pieces of torn or broken components) in the breathing circuit pose a safety risk to the patient during testing procedures. Aspiration of contaminates can potentially be life-threatening. Use disposable anti-bacterial filters or disinfect each part in contact with the patient before each test. 8. You must follow all the cleaning procedures in System Maintenance, and you must thoroughly inspect the components after cleaning and before each patient test. 9. This device is not suitable for use in presence of flammable anaesthetics. It is not an AP nor an APG device (according to the EN 60 601-1 definitions). 10. Keep the device away from heat and flame source, flammable or inflammable liquids or gases and explosive atmospheres. 11. In accordance with their intended use Quark b2 is not to be handled together with other medical devices unless it is clearly declared by the manufacturer itself. 12. It is recommended to use a computer with electromagnetic compatibility CE marking and with low radiation emission displays. 13. It is necessary to make the PC, connected to the Quark b2, compliant with EN 60601-1 by means of an isolation transformer. 14. The Quark b2 needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the section EMC. 15. Portable and mobile RF communications equipment can affect the Quark b2. 16. Use only the cable and accessories supplied with the equipment. The use of accessories and/or cables other than those supplied may result in increased emissions or decreased immunity of the equipment. 17. The Quark b2 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Quark b2 should be observed to verify normal operation in the configuration in which it will be used. 18. Graphical symbols used in accordance to present specifications are described here below: Equipment type B (EN60601-1) Equipment type BF (EN60601-1) Danger: high temperature OFF ON Protective earth ground Alternating current

14 - Quark b2 User Manual

Contraindication The physical strain to execute the respiratory manoeuvre is contraindicated in case of some symptoms or pathology. The following list is not complete and must be considered as a piece of mere information.

Contraindications for the Spirometer tests Absolute contraindications

For FVC, VC and MVV tests: • Post-operating state from thoracic surgery For FVC tests: •

Severe instability of the airways (such as a destructive bronchial emphysema)

•

Bronchial non-specific marked hypersensitivity

•

Serious problems for the gas exchange (total or partial respiratory insufficiency)

Relative contraindications

For FVC tests: •

spontaneous post-pneumothorax state

•

arterial-venous aneurysm

•

strong arterial hypertension

• pregnancy with complications at the 3rd month. For MVV test: •

hyperventilation syndrome

Contraindications for Bronchial provocation tests The bronchial provocation tests must be executed according to the doctor’s discretion. There are not data that reveal specific contraindication for the bronchial provocation test through inhalation. The modern standard processes have been revealing secure in several clinical studies. However it is recommendable to respect the following contraindications: Absolute contraindications

•

Serious bronchial obstruction (FEV1 in adults)

•

Recent myocardium infarct

•

Recent vascular-cerebral accident

•

Known arterial aneurysm

•

Incapacity for understanding the provocation test procedures and its implications.

Relative contraindications

•

Bronchial obstruction caused by the respiratory manoeuvre.

•

Moderate or serious bronchial obstruction. For ex. FEV1 < 1.51 in men and FEV1 in women < than 1.21.

•

Recent infection in the superior air tracts

•

During the asthmatic re-acuting

•

Hypertension

•

Pregnancy

•

A pharmacology treatment epilepsy

Contraindications for Exercise testing Read carefully the exercise testing chapter.

Chapter 1 - Getting started - 15

Environmental condition of use COSMED units have been conceived for operating in medically utilised rooms without potential explosion hazards. The units should not be installed in vicinity of x-ray equipment, motors or transformers with high installed power rating since electric or magnetic interferences may falsify the result of measurements or make them impossible. Due to this the vicinity of power lines is to be avoided as well. Cosmed equipment are not AP not APG devices (according to EN 60601-1): they are not suitable for use in presence of flammable anaesthetic mixtures with air, oxygen or nitrogen protoxide. If not otherwise stated in the shipping documents, Cosmed equipment have been conceived for operating under normal environmental temperatures and conditions [IEC 601-1(1988)/EN 60 601-1 (1990)].

16 - Quark b2 User Manual

•

Temperature range 10°C (50°F) and 40°C (104°F).

•

Relative humidity range 20% to 80%

•

Atmospheric Pressure range 700 to 1060 mBar

•

Avoid to use it in presence of noxious fumes or dusty environment and near heat sources.

•

Do not place near heat sources.

•

Cardiopulmonary resuscitation emergency equipment accessible.

•

Adequate floor space to assure access to the patient during exercise testing.

•

Adequate ventilation in the room.

EMC Guidance and manufacturer’s declaration - electromagnetic emissions The Quark b2 is intended for use in the electromagnetic environment specified below. The customer or the user of the Quark b2 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 The Quark b2 uses RF energy only for its internal function. Therefore, its RF emissions are very low and CISPR 11 are not likely to cause any interference in nearby electronic equipment. RF emissions Class B The Quark b2 is suitable for use in all establishments, including domestic establishments and those directly CISPR 11 connected to the public low-voltage power supply Harmonic Emission Class A network that supplies buildings used for domestic IEC 61000-3-2 purposes. Complies Voltage Fluctuations / Flicker Emission IEC 61000-3-3 Guidance and manufacturer’s declaration - electromagnetic immunity The Quark b2 is intended for use in the electromagnetic environment specified below. The customer or the user of the Quark b2 should assure that it is used in such an environment. Immunity test Test level Compliance level Electromagnetic environment - guidance ±6 kV contact ±6 kV contact Electrostatic Floors should be wood, discharge (ESD) concrete or ceramic tile. If ±8 kV air ±8 kV air floors are covered with IEC 61000-4-2 synthetic material, the relative humidity should be at least 30%. Electrical fast ±2 kV for power ±2 kV for power Mains power quality should transient/burst supply lines supply lines be that of a typical commercial or hospital IEC 61000-4-4 ±1 kV for ±1 kV for environment. input/output lines input/output lines Surge ±1 kV differential ±1 kV differential Mains power quality should mode mode be that of a typical IEC 61000-4-5 commercial or hospital ±2 kV common ±2 kV common environment. mode mode Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

<5% UT (>95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec 3 A/m

<5% UT (>95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec 3 A/m

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Quark b2 requires continued operation during power mains interruptions, it is recommended that the Quark b2 be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note: UT is the a.c. mains voltage prior to application of the test level.

Chapter 1 - Getting started - 17

Guidance and manufacturer’s declaration - electromagnetic immunity The Quark b2 is intended for use in the electromagnetic environment specified below. The customer or the user of the Quark b2 should assure that it is used in such an environment. Immunity test Test level Compliance Electromagnetic environment level guidance Portable and mobile RF communications equipment should be used no closer to any part of the Quark b2, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance

Conducted RF IEC 61000-4-6

3 Veff 150 kHz to 80 MHz

3V

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

d=1.17

P

d=1.17

P 80 MHz to 800 MHz

d=2.33 P 800 MHz to 2.5 GHz where P 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 surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

Notes: (1) At 80 MHz, the higher frequency range applies. (2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a 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 theoretically 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 Quark b2 is used exceeds the applicable RF compliance level above, the Quark b2 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Quark b2. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

18 - Quark b2 User Manual

Recommended separation distances between portable and mobile RF communications equipment and the Quark b2 2 The Quark b is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the Quark b2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Quark b2 as recommended below, according to the maximum output power of the communications equipment.. Separation distance according to frequency of transmitter Rated maximum output power of (m) transmitter (W) 80 MHz to 800 MHz 800 MHz to 2.5 GHz 150 kHz to 80 MHz d=1.17

P

d=1.17

P

d=2.33

P

0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.17 1.17 2.33 10 3.70 3.70 7.38 100 11.70 11.70 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined 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 manufacturer. Notes: (1) At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. (2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Chapter 1 - Getting started - 19

Safety and conformity Safety

IEC 601-1 (1988) /EN 60 601-1 (1990); Find reported below the complete classification of the device: •

Class I type B device

•

Protection against water penetration: IP00, ordinary equipment unprotected against water penetration

•

Non sterile device

•

Device not suitable in the presence of flammable anaesthetics;

•

Continuous functioning equipment;

EMC

The system meets the EMC Directive 89/336 EN 60601-1-2 EN 55011 Class B (emission), IEC 1000-4-2, IEC 1000-4-3, IEC 1000-4-4 Quality Assurance

UNI EN ISO 9001:2000 (Registration n° 387-A Cermet) UNI EN ISO 13485:2003 (Registration n° 387-M Cermet) Medical Device Directive (CE mark)

MDD 93/42/EEC (Notified Body 0476). Class IIa

20 - Quark b2 User Manual

Keynotes Here are the keynotes used to make the manual easier to read.

Typographic keynotes These are the typographic keynotes used in the manual. Style

Description

Bold “Italic”

indicates a control or a key to be pressed. indicates a messages shown by the firmware.

Graphic keynotes These are the graphic keynotes used in the manual. Illustration

Description

shows the button to click in the software to activate the related feature.

Chapter 1 - Getting started - 21