background image

5.

 

Adequate ventilation is required in the disinfection area to evacuate the chemical vapors from glutaraldehyde (if used). Use lidded containers 

for the disinfectant solution when appropriate. The inhalation of fumes from disinfectant solutions or skin contact with liquid disinfectants 
can be hazardous to personnel. 

Warning:

 Particular precautions should be taken when testing patients with high risk communicable diseases (i.e. 

Tuberculosis, Multidrug Resistant Staphylococcus infections, etc.). When such conditions are present the clinical need 
for performing the test should justify the risks. 

When performing the disinfection: 

 

Do not use alcohol or other liquids containing Gluteraldehyde on the exterior surface of the equipment.  

 

Do not use abrasive powders or glass cleaners containing alcohol or ammonia on the plexiglas component (mixing chamber or canopy) of 
the equipment. 

 

Do not steam autoclave any component other then rubber reusable masks (plastic adapter and clips should be removed). 

Warning: 

Do not immerse any parts in liquid unless indicated (see following sections) 

 

Introduction 

Decontamination is a multi-step process that includes preparation at point of use, thorough cleaning and rinsing and a microbicidal process. 

Thorough cleaning and rinsing are the first and most important steps in the reprocessing of any reusable medical device. Without thorough 
cleaning and rinsing it might not be possible to achieve high level disinfection or sterilization of the device. The purpose of cleaning and rinsing is to 

remove all adherent visible soil, to reduce the number of particulates and microorganisms, and to reduce the amount of pyrogenic and antigenic 
material. Any organic material, lubricants, or residual cleaning agents remaining on a device can inactivate liquid chemical disinfectants/sterilants 
as well as protect microorganisms from destruction. 
The second step in decontamination is the microbicidal process which is defined as a process to provide a particular level of microbial lethality (kill). 
COSMED components are classified as "semi-critical" items which are devices that come into contact with intact mucous membranes. Semi-critical 

devices at a minimum require a high-level disinfection procedure. Sterilization is not absolutely essential. 
COSMED components require complete or partial disassembly for cleaning and disinfection. It is the responsibility of the user  (health care 
personnel) for ensuring that: the cleaning methods recommended can be duplicated in their environment, that appropriate tools, and replacement 

parts are available and that instructions are followed correctly. 

 

Cleaning 

Note:

 Please refer to additional, specific cleaning instructions for the turbine assembly below. 

Cleaning Agents/supplies 

Mild detergents with a neutral pH (7) are recommended for cleaning. Use warm water (22°-43°c) with the mild detergent. To be effective, cleaning 
agents must assist in the removal of residual organic soil without damaging the device. cleaning agents should be used in the correct 

dilution/concentration and at the correct temperature in accordance with the cleaning agents manufacturer's directions. 
Cleaning supplies are very basic, usually consisting of a surgical scrub brush, chenille pipe cleaners, cotton or foam tipped applicators, soft brushes, 
and soft cloths. Cleaning supplies should be cleaned and disinfected or sterilized daily. 
Water Quality: tap water is acceptable for use in cleaning COSMED components. 
COSMED components should be soaked and rinsed in tap water at 22°-43°C to prevent the coagulation of solid substances onto the device and thus 
facilitate the removal of debris. 
Enzymatic detergents with a neutral pH (7) are recommended when processing difficult-to-clean items with dried-on matter. Soaking mask and 

valve components in an enzymatic detergent solution can effectively remove visible debris except for lubricants thus providing an acceptable 

alternative to manual cleaning. Rinsing is necessary to remove all traces of detergent and extraneous debris. 

Standard cleaning procedure 

These steps are common to all the cleaning procedures 

Step 1 Preparation at Point of Use. 

The cleaning of reusable items begins soon after use. At the point of use, personnel wearing gloves and 

other protective attire separate disposable items or components from reusable items and discard them in appropriate receptacles. Soil is wiped 
from device surfaces with a moist sponge or towel. The soiled/contaminated items are then contained in a manner that will reduce the risk of 

personal exposure to pathogens. Items are usually placed in a basket, tray or rigid container for transportation to the processing area, usually 

transported in or on a cart, as hand carrying of soiled items is discouraged. 

26 - System maintenance - Cleaning and disinfecting 

Содержание microQuark

Страница 1: ...Manuale Utente User Manual Manuel d utilisation Benutzerhandbuch Manual del Usuario microQuark PC based Spirometer...

Страница 2: ......

Страница 3: ...ransmitted inany form withoutthe expressed writtenpermissionof COSMED Srl Eachcopy of theCOSMED Softwarecanonly beinstalled ononecomputer Excel is aregistered trademark of MicrosoftCorporation DBIIIis...

Страница 4: ...2...

Страница 5: ...e 9 EMC 10 Overview of the manual 14 Introduction 15 MicroQuark overview 16 MicroQuark unit 16 Theflowmeter 16 Paper mouthpieces 17 Antibacterial filters 17 Noseclips 17 Installation 19 Beforestarting...

Страница 6: ...razionedi conformit 32 Service Warranty 33 Warranty and limitationof liability 33 Returngoods policy for warranty or nonwarranty repair 33 Repair ServicePolicy 33 Privacy Information 35 Personal datat...

Страница 7: ...Getting started...

Страница 8: ...nd trained personnel Environmental and electrical conditions in which the device operates should be in compliance with the specifications of this manual In particular grounding reliability and leakage...

Страница 9: ...equipment 14 The device should not be used adjacent to or stacked with other equipment If this is necessary you must verify that the device continues to operatenormally intheconfigurationinwhichit wil...

Страница 10: ...sts Hyperventilationsyndrome Contraindications for Bronchial Provocation testing Bronchial Provocation testing must be executed under the direction of a physician Testing is considered safe when execu...

Страница 11: ...d be operated under normal environmental temperatures and conditions which are defined as follows IEC 60601 1 EN 60601 1 Temperatures range 10 C 50 F and 40 C 104 F Relativehumidity range 30 to 90 not...

Страница 12: ...The device uses RF energy only for its internal function Therefore its RF emissions are very low and arenotlikely tocauseany interferencein nearby electronic equipment RF emissions CISPR 11 Class B T...

Страница 13: ...common mode 1kV differential mode 2kV commonmode Mains power quality should be that of a typical commercial or hospital environment Voltagedips short interruptions and voltage variations onpower suppl...

Страница 14: ...mitters as determined by an electromagnetic site surveya should be less than the compliancelevel ineachfrequency rangeb Interference may occur in the vicinity of equipment marked withthe following sym...

Страница 15: ...cy oftransmitter m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz 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...

Страница 16: ...equiredtoproperly install thedevice Systemmaintenance Describes system maintenanceprocedures Appendix Contains information regarding the warranty treatment of personal data reference standards technic...

Страница 17: ...intelligent flowmeter that connected to a Personal Computer laptop or desktop turns itinacompletespirometric lab The system is composed by the turbine flowmeter the measurement and data elaboration d...

Страница 18: ...The air passing through the helical conveyors takes a spiral motion which causes the rotation of the turbine rotor The rolling blade interrupts the infrared light beamed by the two diodes of the read...

Страница 19: ...infection control However regular cleaning and decontamination of lung function equipment should always beperformed Note The use of antibacterial filters is recommended even when using disposable mout...

Страница 20: ......

Страница 21: ...Installation...

Страница 22: ...should assure that the package contains the items listed in the packing list enclosed with the device If there are any missing or damaged parts you should contactCosmed s technical assistance Options...

Страница 23: ...USBplug Theunitis turnedon off automatically by thePC Insertthe turbineand besureto pushthe turbineup totouchtheend of theholder MicroQuark connects tothePCas showninthefollowing picture 1 microQuark...

Страница 24: ...Piani di Monte Savello 37 00041 AlbanoLaziale Rome ITALY Voice 39 06 931 5492 Fax 39 06 931 4580 email customersupport cosmed it Internet http www cosmed com Complaints feedback and suggestions If yo...

Страница 25: ...System maintenance...

Страница 26: ...oQuark arenon toxic and posenosafety risk tothepatientor operator Prior tothedevicecleaning disinfectionand inspectionit is necessary to switchoff the deviceand todisconnectadapters from thesupply mai...

Страница 27: ...oplet nuclei are likely to be encountered proper attention to environmental engineering controls suchas ventilation air filtration or ultravioletdecontaminationof air should beused topreventdiseasetra...

Страница 28: ...or partial disassembly for cleaning and disinfection It is the responsibility of the user health care personnel for ensuring that the cleaning methods recommended can be duplicated in their environmen...

Страница 29: ...dations inthis sections havebeen retrieved from William A Rutala Ph D M P H David J Weber M D M P H and the Healthcare Infection Control Practices Advisory Committee HICPAC Guidelinefor Disinfectionan...

Страница 30: ...epropeller rotates freely evenwith alow speed air flow 6 Connect the turbineto thereader Precautions to take when cleaning disinfecting and drying the turbine Donot exposethe turbineto highheat or to...

Страница 31: ...of cables plugs and any other visible part by means of simpleinspection whentheequipmentis switched off and adapters or electrical feeders aredisconnected from thesupply mains Extract the turbine from...

Страница 32: ......

Страница 33: ...Appendix...

Страница 34: ...ts of theAnnex I of theMedical DeviceDirective93 42 EEC areclassified inClass IIa their design manufacturing and final checks are performed according the Cosmed s Quality System conform to ISO 9001 20...

Страница 35: ...navoid of the warranty The limited warranty shall not be enlarged diminished or modified by the renderings of technical service from COSMED s agents or employees whentheproductis ordered or following...

Страница 36: ...39 06 9314580 E mail customersupport cosmed it USA contact COSMED USA Inc 2211 NorthElston Suite305 ChicagoIL 60614USA Phone 1 773 645 8113 Fax 1 773 645 8116 email usa sales cosmed it Toensurethatyou...

Страница 37: ...l invoices e Toprovideinformationtotheselected business partners needed tosupply your service How your personal data is treated Your personal data will be stored in an electronic format and protected...

Страница 38: ...ent must becollected separately according to the European Directive 2002 96 EEC Otherwiseitcancausedangerous consequences for theenvironmentand human health Thecrossed outwheeled binmeans thattheprodu...

Страница 39: ...device Devicenotsuitableinthepresenceof flammableanaesthetics Continuous functioning equipment EMC Thesystem meets the Standard IEC 60601 1 2 Quality Assurance UNIEN ISO 9001 2008 Registration n 387 A...

Страница 40: ...Flowmeter Bidirectional digital turbine Flow Range 0 16 l s VolumeRange 12l Accuracy 2 or 20ml s Resistance 0 6cmH2O l s 14l s Mouthpieces 31 and 22 mm Dimensions 150x 45 x 53mm Weight 77g 38 Appendix...

Страница 41: ...Standard for healthy non smoking adults ARRD Vol 10 3 p 57 67 1971 Pereira Brazil Pereira CAC Barreto SP Sim es JG Pereira FWL Gerstler JG Nakatani J Valores de Refer ncia para Espirometria em uma amo...

Страница 42: ...pressures in adults normal values and their relationship to determinants of respiratory function Bull Eur Physiopathol Resp 23 435 439 Automatic diagnosis algorithm Reference Lung FunctionTesting sele...

Страница 43: ...eadeeper breath dFVC 200ml and 5 bestFVC Blow outfaster dFEV1 200ml and 5 FEV1 Thatwas a good test Noerrors FVCreproducible Diff 2maxFVCwithin 0 2l FEV1reproducible Diff 2maxFEV1within0 2 l PEF reprod...

Страница 44: ...D Stanescu D Rodenstein C Veriter Reassesment of interrupter technique for measuring flow resistance in human J Appl Physiol 67 3 933 937 1989 Oximeter National Lung HealthEducationProgram NLHEP Guide...

Страница 45: ......

Страница 46: ...www cosmed com COSMEDsrl ViadeiPianidiMonteSavello37 AlbanoLaziale Rome 00041ITALY O 3906931 5492 F 3906931 4580 info cosmed com cosmed com...

Отзывы: