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Quark PFT
Quark CPET
Quark SPIRO
Manuale Utente
User Manual
Manuel d'utilisation
Benutzerhandbuch
Manual del Usuario

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Summary of Contents for Cosmed Quark PFT

  • Page 1 Quark PFT Quark CPET Quark SPIRO Manuale Utente User Manual Manuel d’utilisation Benutzerhandbuch Manual del Usuario...
  • Page 3 COSMED does not assume any liability for end user interpretation of this user manual or for casual or consequential damages in connection with the provision, representation or use of this documentation. No parts of this manual may be reproduced or transmitted in any form without the expressed written permission of COSMED Srl.
  • Page 4: Table Of Contents

    Table of Contents Table of Contents ................................... 2 Getting Started ..................................7  Important Notices ........................................ 8  Intended Use ......................................... 8 Specific Indications for Use .................................... 8 Measured Parameter Table .................................... 9  Warnings ........................................9  Contraindications ....................................... 11 ...
  • Page 5  Mask Leak Test ......................................36 The HR Monitor ......................................37 ECG Electrodes ......................................38 Testing with a Mouthpiece ..................................39  Contact COSMED ........................................ 40 Comments, Feedback and Suggestions ............................... 40 System Cleaning & Maintenance ............................41  System Maintenance ......................................42 ...
  • Page 6  Other precautions and warnings .................................. 43  Decontamination ......................................45  Pretreatment ....................................... 45  Water .......................................... 45  Maintenance ....................................... 45  Procedure For Third-Party Products ................................45  Symbols ........................................45  Spirometry Tests ........................................ 46  Cleaning and Disinfection Methods ................................ 47 ...
  • Page 7 analyzer ........................................92 analyzer ........................................ 92 CO analyzer ......................................... 92 analyser ........................................ 92 Humidity absorber ...................................... 92 Power Supply ......................................92 Environmental Sensors ....................................92 Dimension and Weight ....................................92 Oximeter ........................................92 Accuracy specifications....................................92  Refernces - Calculations ..................................... 93 ...
  • Page 9: Getting Started

    Getting Started...
  • Page 10: Important Notices

     Intended Use The COSMED Quark Series is a modular system with multiple configurations which can perform the following tests: Spirometry, Lung Function, Cardiopulmonary Exercise, and Resting Metabolic Testing. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic parameters.
  • Page 11: Measured Parameter Table

    The manufacturer may offer suggestions while using third-party accessories and the complications which may occur • Device Service and Repair should ONLY be performed by COSMED authorized and trained personnel • Environmental and electrical conditions in which the device operates must comply with this manual. Note that the reliability of the device ground and leakage current suppression is only assured when the three-wire power cord is connected to a grounding point (yellow-green return connected to earth ground).
  • Page 12 10. The device should be used with a computer with electromagnetic compatibility, CE marking and low radiation emission displays 11. The PC connected to the device must be compliant with EN 60601-1 by means of an isolation transformer 12. Precautions regarding EMC should be taken prior to installation and can be noted in the section EMC 13.
  • Page 13: Contraindications

     Contraindications Performing forced expiratory maneuvers in spirometry testing may be contraindicated as outlined below.  Contraindications for the Spirometry Absolute Contraindications FVC, VC and MVV tests: Post-operative thoracic surgery patients  FVC tests: • Severe instability of the airways (patients with severe Emphysema) •...
  • Page 14: Contraindications For Exercise Testing

     Contraindications for Exercise Testing Absolute Contraindications • Acute MI (within the past 2 days) • High-risk/unstable angina • Uncontrolled cardiac dysrhythmias causing symptoms of hemodynamic compromise • Active endocarditis • Symptomatic severe aortic stenosis • Decompensated symptomatic heart failure •...
  • Page 15: Environmental Conditions For Operation

    2. COSMED devices should not be installed near electrical or magnetic devices such as x-ray equipment, transformers or power lines. These devices could create electrical interference when performing testing procedures. 3. COSMED devices are not AP or APG units (according to EN 60601-1) and should never be operated in the presence of flammable anaesthetic mixtures 4.
  • Page 16: Overview

     Overview This manual is organized in the following chapters: 1. Getting Started –Describes the intended use of the device, how to properly use it and features of the unit and accessories 2. Installation – Lists the steps required to properly install the device 3.
  • Page 17: Introduction

      Mixing Chamber  Standard  Optional The Quark Spiro and Quark PFT must be configured with either the turbine flowmeter or X-9 PNT Each module will allow the following tests to be performed: Module Tests Available Spirometry FVC, VC, MVV...
  • Page 18: System Overview

     System Overview The Quark Series consists of the following main parts: • Quark unit • Flowmeter • Breathing valve (if required) • Additional external sensors and devices (temperature-humidity, HR, oximeter)  Quark Unit The Quark unit contains the following elements: •...
  • Page 19: Pneumotach X9 (Pnt)

    The ID28 flowmeter can be used for all tests except for RMR testing and is provided with the Quark PFT and Quark CPET units and CPET module The ID28 Spiro flowmeter is identical to the ID28 with the absence of a sampling line. This flowmeter should only be used for spirometry testing when exhaled gas analysis is not necessary.
  • Page 20: Hans Rudolph V2 Exercise Testing Mask

     Hans Rudolph V2 Exercise Testing Mask The exercise test masks are made of silicone and may be reused after proper disinfection (see the chapter System Cleaning & Maintenance). These blue masks are available in different sizes and should be assembled the included head cap as shown in the chapter Exercise testing. Mask without Inspiratory Valves Mask with Inspiratory Valves (Required for Exercise Flow Volume Loops)
  • Page 21: Paper Mouthpieces

     The canopy hood allows mixes the exhaled air from the subject with ambient air. This mixture is then drawn by a pump with a known flow and the subject’s Oxygen Consumption, CO production and Energy Expenditure can be calculated.Paper mouthpieces Paper mouthpieces are available for simple spirometry tests (FVC, VC, and MVV).
  • Page 22: Nose Clips

     Nose Clips Nose clips should be used during spirometry testing to prevent respiration through the nasal passage while performing testing maneuver  HR Monitor The HR Monitor consists of three parts: the elastic belt containing the transmitter and the USB receiver. The parts should be near one another for the most effective communication signal ...
  • Page 23: Mixing Chamber

     Mixing Chamber The mixing chamber is a 8.7-liter plexiglass cylinder for resting or exercise or resting dtudies utilizing the mixing chamber modality instead of breath- by-breath  Dosimeter The dosimeter is comprised of a nebulizer and accessories used to deliver the bronchoprovocator to the subject during bronchoprovocation tests. The package includes nebulizer, tube to connect to quar, mouthpiece and multiple adapters, detailed information on operation can be found in the Dosimeter chapter Getting Started - System Overview - 21...
  • Page 24: System Warm-Up

     System Warm-Up Each Quark unit must be warmed up prior to use for the required amount of time. The warm-up time depends on which test is being performed. Below is a table displaying minimum warm-up times based on each test: Test Warm-up Time (mins) FVC, VC, MVV...
  • Page 25: Installation

    Installation...
  • Page 26: Before Starting

     Before Starting Before operating any model in the Quark Series, the equipment must be inspected and the COSMED Installation-Training Report completed  Checking the Packing contents • Check the items shipped against the Packing Slilp / Invoice to ensure all items have arrived. If any piece is missing, note it on the Installation- Training Report And contact COSMED Education for assistance (education@cosmed.com)
  • Page 27: Options / Accessories

     Options / Accessories The following Options / Accessories are available with the Quark system: Quantity Description A 860 000 004 Calibration cylinder (5% CO , 16% O , balance N A 860 000 005 DLCO cylinder (0.3% CO, 0.3% CH , 21% O , bal.
  • Page 28: System Description

     System Description The Quark system consists of the main unit, modules and accessories. The following picture displays the correct assembly. 1. Trolley 2. Trolley Top 3. Supply Drawer 4. Printer shelf 5. Accessory shelf 6. Gas Cylinders 7. Quark unit 8.
  • Page 29: Quark Installation

     Quark Installation Before operating the Quark Unit, the required environmental conditions should be verified to be within the acceptable range, for more information, refer to the Environmental Conditions for Operation seciton  Quark front panel Power switch LED power indicator on/off Sampling line Calibration port Installation - Quark Installation - 27...
  • Page 30: Quark Unit Rear Panel

     Quark Unit Rear Panel 12 13 18 19 Connection Description Quark Model 1. PNT/MIP-MEP/P0.1 port Pneumatic connection for X9 PNT and MIP-MEP/P0.1 PFT, SPIRO 2. Permapure sampling line port Connection for the sample line, luer lock, rotate clockwise to tighten PFT, CPET 3.
  • Page 31: Gas Cylinders (Calibration And Testing)

     Gas Cylinders (Calibration and Testing) Sensor calibration requires specific gas mixtures, table below outlines gases required: Cylinder Recommended Gas Mixture Test Calibration 16.0%, CO 5.0%, Balance N FRC, CV, CPET, RMR DLCO CO 0.3%, CH 0.3%, O 21.0%, Balance N DLCO Oxygen 100 %...
  • Page 32: Connect The Hoses To The Regulators

    Connect the hoses to the regulators The following table outlines the appropriate coloured connector for each cylinder in use Connect the hoses to the Quark Warning: The gas tank must be off prior to connecting the cylinders to the Quark (turn counter clockwise to ensure “off”) Match the colored connector push hose and connector into port on Quark 2.
  • Page 33: Turbine

    Turbine 1. Breathing valve 2. Turbine 3. Antibacterial filter PNT X9 1. Breathing valve 2. PNT X9 3. Antibacterial filter Note: in order to obtain reliable measurements, the PNT X9 must be always used with the antibacterial filter.  Attach the flowmeter to the handle with turbine with PNT X9 Handle...
  • Page 34: Connect The Breathing Valve And/Or The Flowmeter To The Quark

     Connect the breathing valve and/or the flowmeter to the Quark 12 13 18 19 Connecting the breathing valve (if present) and the flowmeter to the Quark rear panel: 5. Breathing Valve - The two tubes coming from the breathing valve must be connected to connectors #3 and 7 on the rear panel of the Quark (Breathing valve and Demand valve).
  • Page 35: Assemble The Rpnt

     Assemble the R 1. Occlusion valve 2. Reader 3. PNT  Connect the Quark to the computer (PC) Connect the Quark unit to the PC using the USB or RS232 ports with the appropriate cable (USB or RS232) to the proper (USB or COM) Quark and PC ports ...
  • Page 36: Prepare The Quark Unit And Subject For Exercise Testing

     Prepare the Quark Unit and Subject for Exercise Testing Note: If the exercise test must include flow/volume loop events, it is mandatory to use masks without valves (REF C04490-01-10 extra small, C04490-02-10 small, C04490-03-10 medium)  Prepare the Quark Connect the head cap, the VO max mask and the ID28 turbine as shown in the following picture: •...
  • Page 37: Assemble The Flowmeter And Mask

    Measurement Mask Size Distance (in) Distance (mm) Too small 3.60” Petite (P) 4.00”” Extra Small (XS) 4.40” Small (S) 4.90” Medium (M) 5.40” Large (L) 5.90”  Assemble the Flowmeter and Mask 1. Construct Flowmeter Assembly a) Insert the turbine in mask adapter and lock in place by rotating 1/8 turn clockwise, there will be small resistance, DO NOT FORCE the rotation as this can damage parts b) Slide the optoelectronic reader over the turbine, the tapered end will correspond to the smaller connector of the turbine, cable should be oriented down...
  • Page 38: The Mask

    The Mask  Secure the mask Pictures below demonstrate proper mask placement After securing mask, adjust head cap and secure Velcro to form a tight seal and perform a leak test, described below  Mask Leak Test After the mask is secured to the subject, the best practice is to perform a leak test according to the following steps: 1.
  • Page 39: The Hr Monitor

    Turbine Attached Turbine Not Attached No Inspiratory Valves “Inspire” Inspiratory Valves “Expire” Wind shield not attached Hand over open end, occlude and Instructions Hand over open end, occlude and have subject breathe as shown have subject breathe as shown The HR Monitor Assemble the HR Monitor Belt: 1.
  • Page 40: Ecg Electrodes

    ECG Electrodes Proper electrode placement is important for acquiring a clean ECG signal. Subject preparations which can improve signal quality include removal of oil, lotions and hair from the skin: 1. Shave the areas where the electrodes will be placed 2.
  • Page 41: Testing With A Mouthpiece

    Testing with a Mouthpiece Sub-maximal tests (with ventilation values maintained at less than 100 L/min), it is possible to use a rubber mouthpiece, anti-bacterial filter and nose clip in place of the mask Assemble the mouthpiece, filter and reader as illustrated in the picture below. Ensure that no leaks are present between the patient and the mouthpiece.
  • Page 42: Contact Cosmed

    Rome - ITALY Voice: +39 (06) 931.5492 Fax: +39 (06) 931.4580 email: customersupport@cosmed.com Internet: http: //www.cosmed.com Comments, Feedback and Suggestions If you have any comments, feedback or suggestions you may inform us at complain@cosmed.com 40 - Installation - Contact COSMED...
  • Page 43: System Cleaning & Maintenance

    System Cleaning & Maintenance...
  • Page 44: System Maintenance

     System Maintenance Any service operations not specified in this manual should only be only performed by authorized personnel in accordance with the service manual. Rubber mouthpieces, face masks, breathing valves and the other parts are not shipped sterile, therefore these items should be disinfected prior to first useAll materials used in the construction of the Quark and its accessories are nontoxic and pose no safety risks to the patient or operator.
  • Page 45: Cleaning & Disinfection

     Cleaning & Disinfection  Introduction The goal of infection control is to prevent the transmission of infection to patients/subjects and staff during pulmonary function testing. Cleaning and disinfecting instructions should be strictly followed to control infections and assure the safety of the patient. Aspiration of residue, particles and/or contaminated agents could be life threatening.
  • Page 46 To avoid cross-contamination, all contaminated parts must be thoroughly disinfected or disposed of. COSMED components which come into (direct or indirect) contact with mucosa or broken skin are classified as “semi-critical” devices and require high-level disinfection according to applicable regulatory bodies. All other components are classified as non-critical.
  • Page 47: Decontamination

    The pretreatment should be performed immediately after use  Water A sterile water rinse is recommended, when available, although tap potable water is also acceptable for use in cleaning COSMED components  Maintenance The applied parts which have been disassembled, must be reassembled following Cleaning & Disinfection according to the installation section of this manual.
  • Page 48: Spirometry Tests

     Spirometry Tests 46 - System Cleaning & Maintenance - Spirometry Tests...
  • Page 49: Cleaning And Disinfection Methods

     Cleaning and Disinfection Methods Always follow the instructions on the cleaning agent for solution mixing and personal protective equipment (PPE) Item Turbine Adapter When? Before first use and immediately after use Before first use and immediately after use Notes DO NOT use running water to rinse the item DO NOT brush the inside of the turbine Pretreatment Rinse the component in tap water at 22-40°C Rinse the component in tap water at 22-40°C...
  • Page 50 Item Turbine PNT X9 When? Before first use and immediately after use Daily Notes 1. Do not place the turbine under running water or 1. Use distilled water for preparing the disinfectant move the turbine while submerged solution, otherwise calcium deposits could damage the flowmeter mesh Do not use a brush for the internal part of the turbine, doing so will damages to the turbine blade...
  • Page 51 Item Flowmeter Sampling line tip When? Before first use and immediately after use Before first use and immediately after use Note Do not clean and disinfect the internal surface of the Lubricate the O-ring of the sampling line plug after reader cleaning with biocompatible lubricant Pretreatment Wipe soil with a moist sponge or lint-free towel...
  • Page 52 Item Closing Ring Dosimeter When? Before first use and immediately after use Before first use and immediately after use To verify the proper functioning of the device after the Note reprocessing please refer to ATS document “Guidelines for Methacholine and Exercise Challenge Testing-1999” Pretreatment Rinse the component in tap water at 22-40°C Please refer to the manufacturer’s cleaning and disinfection instructions provided...
  • Page 53 Item Breathing Valve Demand Valve Remove the demand valve (a) from the breathing valve. Pay attention to the net behind it. Unscrew the tube (b) Remove the cover on the rear of the breathing valve by means of a coin Remove the membrane paying attention to its orientation (must not be...
  • Page 54 Item Handle Before first use and immediately after use When? Do not clean and disinfect the internal surface of the reader Pretreatment Wipe soil with a moist sponge or lint-free towel Manual Cleaning Wipe with a damp soft cloth Disinfection Wear recommended PPE.
  • Page 55: Disposable Items

     Disposable items Description Item When? Note After each test PTE soft mouthpieces After each test Antibacterial filter Paper mouthpieces After each test Nose clips After each test System Cleaning & Maintenance - Spirometry Tests - 53...
  • Page 56: Cpet & Rmr Tests

     CPET & RMR Tests 54 - System Cleaning & Maintenance - CPET & RMR Tests...
  • Page 57: Cleaning And Disinfection Mmethods

     Cleaning and Disinfection Mmethods Item Headgear Mask When? Before first use and after every use Before first use and immediately after use Note DO NOT iron Disassemble all parts prior to cleaning Pretreatment Rinse the component in tap water at 22-40°C Rinse the components in tap water at 22-40°C Manual Cleaning 1.
  • Page 58 Item Turbine Windshield When? Before first use and immediately after use Before first use and immediately after use DO NOT use running water to rinse the item Notes DO NOT brush the inside of the turbine Pretreatment Rinse the component in tap water at 22-40°C Rinse the component in tap water at 22-40°C 1.
  • Page 59 Item Turbine Flowmeter (ID18) Closing ring When? Before first use and immediately after use Before first use and immediately after use Note 1. Do not place the turbine under running water or move the turbine while submerged Do not use a brush for the internal part of the turbine, doing so will damages to the turbine blade For cleaning and rinsing, do not wet the sampling line.
  • Page 60 Item Flowmeter Sampling line tip When? Before first use and immediately after use Before first use and immediately after use Note Do not clean and disinfect the internal surface of the Lubricate the O-ring of the sampling line plug after reader cleaning with biocompatible lubricant Pretreatment Wipe soil with a moist sponge or lint-free towel...
  • Page 61 Item Mask adapter When? Before first use and immediately after use Pretreatment Rinse the component in tap water at 22-40°C Manual Cleaning 1. Soak for 3 minutes in a mild detergent solution (Cidezyme) at room temperature (>22°C). Using a soft bristle brush, scrub the item submerged in the cleaning solution during the 3 minutes 2.
  • Page 62: Disposable Items

     Disposable Items Description Item When? Note After each test PTE soft mouthpieces After each test Antibacterial filter Nose clips After each test 60 - System Cleaning & Maintenance - CPET & RMR Tests...
  • Page 63: Mixing Chamber Test

     Canopy test System Cleaning & Maintenance - Canopy test - 61...
  • Page 64  Cleaning and disinfecting methods Item Canopy hood Canopy veil When? Immediately after use Immediately after use Pretreatment Wipe soil with a moist sponge or towel. Wipe soil with a moist sponge or towel. Manual Cleaning Wipe with a wet soft cloth. Wipe with a wet soft cloth.
  • Page 65 Item Turbine Flowmeter Corrugated tube When? Before first use and immediately after use Before first use and immediately after use Note 1. Do not place the turbine under running water or move the turbine while submerged Do not use a brush for the internal part of the turbine, doing so will damages to the turbine blade For cleaning and rinsing, do not wet the sampling line.
  • Page 66 Item Canopy device case When? Daily Note Cleaning only Pretreatment Wipe soil with a moist sponge or lint-free towel Manual Wipe the device with a wet soft cloth Cleaning Disinfection Not applicable (not in contact with subject) Cleaning Time 1 minute Drying Time 1 minute 64 - System Cleaning &...
  • Page 67  Disposable Items Description Item When? Note After each test Protects canopy hose and device Antibacterial filter from possible cross contamination. System Cleaning & Maintenance - Canopy test - 65...
  • Page 68  Mixing Chamber Test 66 - System Cleaning & Maintenance - Mixing Chamber Test...
  • Page 69: Cleaning And Disinfection Methods

     Cleaning and Disinfection Methods Item Headgear Mask When? Before first use and after every use Before first use and immediately after use Note DO NOT iron Disassemble all parts prior to cleaning Pretreatment Rinse the component in tap water at 22-40°C Rinse the components in tap water at 22-40°C Manual Cleaning 1.
  • Page 70 Item Adapter 1 Adapter 2 When? Before first use and immediately after use Before first use and immediately after use Pretreatment Rinse the component in tap water at 22-40°C Rinse the component in tap water at 22-40°C Manual Cleaning 1. Soak for 3 minutes in a mild detergent solution 1.
  • Page 71 Item Two-way Non-Rebreathing Valve Corrugated Tube When? Immediately after use Immediately after use For additional information please refer to the indications Note reported in the sheet shipped together with the valve Pretreatment Rinse the component in tap water at 22-40°C Rinse the component in tap water at 22-40°C Manual Cleaning 1.
  • Page 72 Item Adapter Adapter 3 When? Before first use and immediately after use Before first use and immediately after use Pretreatment Rinse the component in tap water at 22-40°C Rinse the component in tap water at 22-40°C Manual Cleaning 1. Soak for 3 minutes in a mild detergent solution 1.
  • Page 73 Item Turbine Flowmeter (ID28) Closing ring When? Before first use and immediately after use Before first use and immediately after use Note DO NOT use running water to rinse the item DO NOT brush the inside of the turbine Pretreatment Rinse the component in tap water at 22-40°C Rinse the component in tap water at 22-40°C Manual Cleaning 1.
  • Page 74 Item Flowmeter Sampling line tip When? Before first use and immediately after use Before first use and immediately after use Note Do not clean and disinfect the internal surface of the Lubricate the O-ring of the sampling line plug after reader cleaning with biocompatible lubricant Pretreatment Wipe soil with a moist sponge or lint-free towel...
  • Page 75 Item Head support Mixing chamber (rounded) When? Immediately after use Daily Note 1. After reprocessing, reassemble and carefully close the mixing chamber 2. Air passes through the chamber in a unidirectional way, from the patient to the device; thus, only a daily reprocessing is required.
  • Page 76: Disposable Items

     Disposable items Description Item When? Note After each test PTE soft mouthpieces After each test Nose clips 74 - System Cleaning & Maintenance - Mixing Chamber Test...
  • Page 77: Rocc Test

     Rocc test  System Cleaning & Maintenance - Rocc test - 75...
  • Page 78: Cleaning And Disinfection Methods

     Cleaning and Disinfection Methods Item Reader Occlusion valve When? Immediately after use Immediately after use Note Do not place the component under running These items are protected by the antibacterial filter water. Pretreatment Wipe soil with a moist sponge or towel. Rinse the component in tap water at 22-40°C Manual Cleaning Wipe with a wet soft cloth.
  • Page 79: Disposable Items

     Disposable Items Description Item When? Note After each test PTE soft mouthpieces After each test Antibacterial filter Nose clips After each test System Cleaning & Maintenance - Rocc test - 77...
  • Page 80: Sampling Line Maintenance (Permapure)

     Sampling line maintenance (Permapure) • Do not bend, squash or deform the sampling line. Any “kink” in the sample line will reduce the internal lumen of the line and affect accuracy of measurement. • Do not keep the sampling line open to the atmosphere, particularly in crowded or smoky environments. Keep the sampling line in sealed plastic bag in a dark cool and dry place.
  • Page 81: Equipment Inspection

     Equipment Inspection The equipment requires inspections to be carried out to assure proper electrical and mechanical safety levels. The inspections are recommended after extensive use of the equipment or after a long period of storage in unfavourable environmental conditions. The insulation materials of cables, plugs and any other visible parts should also be inspected.
  • Page 82: Fuse Replacement

     Fuse Replacement The fuses can be replaced by follow the following steps 1. Open the power supply cover using a screwdriver 2. Extract the fuse holder 3. Replace the damaged fuse(s) Note: Ensure that the appropriate fuses are used when replacing previous fuses: A-680-024-125 (Time Lag Fuses 5x20 250V T1.25A) 80 - System Cleaning &...
  • Page 83: Appendix

    Appendix...
  • Page 84: Emc

     Guidance and manufacturer’s declaration - electromagnetic emissions The device is intended for use in the environment below. User should not operate the system outside of this environment Emissions test Compliance Electromagnetic environment – guidance RF emissions Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
  • Page 85 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The device is intended for use in the environment below. User should not operate the system outside of this environment Immunity test Test level Compliance level Electromagnetic environment – guidance IEC 60601-1 Electrostatic discharge ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic tile...
  • Page 86 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test Test level Compliance level Electromagnetic environment –...
  • Page 87 Recommended Distances Between Portable RF Equipment and the Device The device is intended for use in an environment in which RF disturbances are controlled. The customer or user can prevent electromagnetic interference by maintaining a minimum distance between RF equipment (transmitters) and the device as recommended in the table below Rated maximum Separation distance according to frequency of transmitter output power of...
  • Page 88: Declaration Of Conformity

    • are classified in Class IIa; • their design, manufacturing and final checks are performed according the Cosmed’s Quality System, conform to ISO 9001:2008 and ISO13485:2003 Norms, certified by KIWA CERMET (certificates nr. 387-A and 387-M); • are CE marked according to the Medical Device Directive 93/42/EEC and subsequent amendments, and certified by KIWA CERMET (certificate nr.
  • Page 89: Service - Warranty

    Warranty and limted of liability COSMED provides a one-year limited warranty from the date of the original sale of the product. COSMED products are guaranteed to be free from defect upon shipment. Liability for products covered by this warranty is limited to the replacement, repair or issuance of a credit for the cost of the defective product at the discretion of COSMED.
  • Page 90 • Net weight • Reason for repair If repairs are needed, you may contact COSMED at the one of the following addresses: COSMED S.r.l. Via dei Piani di Monte Savello 37 P.O. Box 3 00041 Pavona di Albano - Rome, Italy tel.
  • Page 91: Privacy Information

    Dear Customer, We would like to inform you that your personal data is gathered and will be used by COSMED Srl in conformity with the requirements of the Italian privacy law (Decreto Legislativo 196/2003). We believe it is important for you to acknowledge how your personal data is handled.
  • Page 92: Disposing Of Electrical Equipment

     Disposing of electrical equipment The device cannot be disposed as unsorted municipal waste. Electronic equipment must be collected separately according to the European Directive 2012/19/UE. Otherwise it can cause dangerous consequences for the environment and human health. The crossed-out wheeled bin means that the product must be taken to a separate collection when you wish to dispose of it. 90 - Appendix - Disposing of electrical equipment...
  • Page 93: Safety And Conformity

     Safety and conformity Safety IEC 60601-1/EN 60601-1; The complete classification of the device is as follows: • Class I with applied parts type B and BF • Protection against water penetration: IPX1 • Non sterile device • Device not suitable in the presence of flammable anaesthetics •...
  • Page 94: Technical Specifications

     Technical Specifications Flowmeter ID28 turbine ID18 turbine Type: Bidirectional Bidirectional PNT Lilly Diameter (int.): 28mm 18mm 28mm Flow range: 0-16 l/s 0-8 l/s 0-14 l/s Volume range: 0-300 l/min 0-50 l/min Resolution: 12 ml 3 ml 1 ml Accuracy: ±...
  • Page 95: Refernces - Calculations

     Refernces - Calculations  and VCO "Energy Expenditure and Fuel Selection in Biological Systems: The Theory and Practice of Calculations Based on Indirect Calorimetry and Tracer Methods": M. Elia, G. Livesey, World Rev. Nutr. Diet. Basel, Karger, 1992, vol 70, pp 68-131. "Nutritional Assessment in Critical Care, A Training Handbook": Donald C.
  • Page 96: Predicted Sets

     Predicted Sets ERS93 Standardized Lung Function Testing: Official Statement of the European Respiratory Society, The European Respiratory Journal Volume 6, Supplement 16, March 1993. Compilation of reference values for lung function measurements in children: Ph. H. Quanjer, J. Stocks, G.Polgar, M. Wise, J. Karlberg, G. Borsboom; ERJ 1989, 2, Supp.4,184s-261s.
  • Page 97: Automatic Diagnosis (Algorithm)

    Compilation of reference values for lung function measurements in children: Ph. H. Quanjer, J. Stocks, G.Polgar, M. Wise, J. Karlberg, G. Borsboom; ERJ 1989, 2, Supp.4,184s-261s. Reference Values for Residual Volume, Functional Residual Capacity and Total Lung Capacity - ATS workshop on Lung Volume measurements, official statement of the European Respiratory Society;...
  • Page 98: Quality Control Messages

     Quality Control Messages Reference: Spirometry in the Lung Health Study: Methods and Quality Control, ARRD 1991; 143:1215-1223. Message Criterion Start faster VEXT >5% of the FVC and >150ml Blast out harder PEFT >120 msec Avoid coughing 50% drop in the flow in first second. Blow out longer FET100% <6 sec.
  • Page 99: References

     References Spirometry ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION TESTING, Edited by V. Brusasco, R. Crapo and G. Viegi: Standardisation of spirometry, Eur Respir J 2005; 26: 319–338 Lung function", J.E. Cotes, Blackwell scientific publications "Guidelines for Clinical Exercises Testing Laboratories", I.L. Pina, G.J. Balady, P. Hanson, A.J. Labovitz, D.W. Madonna, J. Myers. American Heart Association.
  • Page 100: Indirect Calorimetry

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