CareFusion Pulmolife Instructions for Use Issue 1.3 Feb 2010

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English

Turbine Swirl Plate

Turbine Housing

Scroll Up

On/Off Enter (New Blow)

Scroll Down

ABOUT PULMOLIFE PulmoLife quickly and easily screens smokers for early detection of Chronic Obstructive Pulmonary Disease (COPD). The effects of COPD in smokers is normally detectable from the age of 35. The unit measures the Forced Expiratory Volume in the First Second of Expiration (FEV1) and the FEV1 as a Percentage of the Predicted Value (FEV1% predicted). The use of FEV1 is a useful diagnostic tool for early detection of COPD1. The results can also be used to calculate and display an equivalent ‘Lung Age’2 This information can help in the diagnosis, management and treatment during the early stages of COPD development. The use of ‘Lung Age’ provides an additional motivational tool that may help susceptible smokers to understand the physical damage caused by smoking.

BEFORE USING YOUR PULMOLIFE YOU MUST REMOVE THE BATTERY CONNECTION TAB

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ENTERING PATIENT DETAILS Patients predicted values are based on their Sex, Height, Age and Race (default predicted value set shown on box, to change see Predicted Value Set Up) Switch the unit On

to begin.

When entering patient details use the Scroll Up / Down change values and the Enter key to accept and proceed.

keys to

Enter Sex (Male/Female) Enter Height (cm for ECCS and Asian, inches for NHANES III) Enter Age (Default is 45) Enter Race (for ECCS and NHANES III only) The display will show the blow symbol

and 0.00.

PERFORMING A TEST Also see furthur instructions in the PulmoLife box. Insert a new disposable one-way valve mouthpiece into the turbine holder. With the display showing the blow symbol

and 0.00.

Instruct the patient to breathe in until their lungs are completely full, seal their lips around the mouthpiece, and blast out as hard and as fast as possible for at least one second. After one second the unit will emit a beep to signal the end of the blow. IMPORTANT NOTE: The rear of the turbine must not be obstructed during the blow.

The FEV1 and FEV1% predicted will be displayed.

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If a blow is too slow at the beginning of the manoeuvre3, the blow icon will flash assessing this test as poor quality and the test should be repeated. After a full inspiration the patient should be encouraged to blast out the air as fast as possible without hesitation. When FEV1% predicted is less than or equal to 80% of predicted, the FEV1% predicted value will flash indicating the possibility of airways obstruction. Press the Scrolling Down key to display the ‘Lung Age’ (range 20-90 years) and smoker visual.A patient’s ‘Lung Age’ is limited to 30 years over their chronological age up to a maximum age of 90. PLEASE NOTE: If a patients FEV1 %predicted is above 100% of predicted then their estimated ‘Lung Age’ would be lower than their chronological age.

Use the scrolling Up both results screens. Press Enter

/ Down

keys to move back and forth between

to perform a new blow.

It is recommended that a spirometry result should be taken from the best of 3 technically correct blows. To test another patient the unit must be switched off and on and then enter the new patient details.

CLEANING CareFusion recommends the use of One-Way Valve Disposable Mouthpieces for all multi-patient use devices. To remove the turbine, simply press the turbine from the rear, without excessive force, and the turbine will pop out. The turbine may be immersed in warm soapy water for routine cleaning. T­ o sterilise, immerse the turbine in a cold-water solution (e.g. PeraSafe) for a period not exceeding 10 minutes. NOTE: Do not use alcohol or chloride based solutions.

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After cleaning/sterilising, the turbine should be rinsed in distilled water and left to dry. Do not use objects, such as pens or cotton buds, to clean or dry the turbine, as this may cause irreparable physical damage. To replace the turbine hold the unit and the turbine swirl plate facing you, put the turbine back into the turbine housing then push until the turbine is fully located, such that the back of the turbine is completely level with the back of the unit.

The PulmoLife moulding can be wiped clean using a damp cloth or surgical wipe.

CALIBRATION CHECK The unit should not require recalibration. However, as a confirmation of the correct functioning of the unit, the calibration can be checked using a 3-litre calibration syringe. To check the calibration hold down the On and Scrolling Up together, and only release when ‘Ch’ is displayed.

keys

When the blow symbol and ‘0.00’ appear, empty the 3-litre syringe smoothly into the unit. The value will be displayed. If the unit detects an error the blow symbol and calibration value will flash. An acceptable calibration check is within +/-3% of the 3-litres entered (so between 2.91 and 3.09 litres). PLEASE NOTE: Calibration check failure is unusual but is most often due to malfunction of the turbine, either because it is physically damaged or dirty. Clean the turbine (see cleaning) and recheck the calibration. If the unit still fails calibration check, replace with a new turbine (see accessories for order number).

SERVICE This unit requires no routine servicing.

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BATTERY If the battery level is low the unit will display the letters ‘bAt’. If switched on with a low battery level, the unit will beep three times and then turn off after 5 seconds. The battery is contained beneath the slide cover in the rear of the unit. To replace, simply slide the cover away, change the battery and replace the cover. PLEASE NOTE: If the battery is removed for any reason the unit will reset to factory predicted value settings. Replacement 3V coin cell batteries are available at most major electrical outlets. Please be sure to dispose of the lithium ion coin cell battery according to standard local environmental procedures.

PREDICTED VALUE SET UP To change the Predicted Value Settings, from the default shown on the box, hold down the On and Enter keys together, and only release when ‘Prd’ is displayed. Use the Scrolling Up / Down keys to choose an alternative Predicted Value set. 1 ECCS4 2 NHANES III5 Asian (Chinese)6 When the desired number is selected press the Enter save that predicted value set as default.

key to accept and

VERSION To check the version number, hold down the On and Scrolling Down keys together, and only release when ‘rE’ is displayed. The version number will then be shown.

ACCESSORIES Adult disposable mouthpieces with one-way valve (Box of 500)

36-SST1000

PeraSafe Sterilizing Solution 81g

36-SSC5000A

Pouch

36-CAS1048

Replacement Turbine

36-ASS1148

CAUTION: Mouthpieces are single patient use. If used on more than one patient there is a risk of cross-infection. Repeat use may degrade materials and lead to an incorrect measurement.

English SPECIFICATIONS Transducer:

Digital Volume Transducer

Resolution:

0.01L

Accuracy:

+/-3% To ATS/ERS Taskforce Standardisation of Spirometry, 2005

Volume Range:

0 - 8 L As per ATS/ERS

Flow Range:

0-14 L/s As per ATS/ERS

recommendations recommendations Predicted Values

1) ECCS 2) NHANES III 3) Asian (Chinese)

Display:

Custom Liquid Crystal

Power Supply:

3V Lithium Ion Coin Cell Battery (model no CR-2450)

Dimensions:

131 x 59 x 38 mm

Weight:

Unit only: 96g Unit complete with accessories: 260g

Operating Temperature:

0O to +40O C

Operating Humidity:

30% to 90% RH

Storage Temperature:

-20O to + 70O C

Storage Humidity:

10% to 90% RH

SYMBOLS Type B device In accordance with Directive 93/42/EEC Disposal in compliance With WEEE

ENVIRONMENT This instrument complies with directive EN60601-1-2 electromagnetic compatibility but can be affected by cellular phones and by electromagnetic interference exceeding levels specified in EN 50082-1:1992

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1.

References / Références / Hinweise / Bibliografía / Referenties / Bibliografia / Referências Nice COPD Guidelines 2004, Thorax 2004: 59 (suppl1): 1-232

2.

Morris JF, Temple W. Spirometric ‘Lung Age’ estimation for motivating smoking cessation. Preventative Medicine, 1995; 14 655-662

3.

ATS/ERS Task Force Standardisation of Spirometry 2005 Update, Eur Respir J 2005; 26: 319-338

4.

European Respiratory Journal. Vol 6, Supplement 16 March 1993 Pages 26,27.

5.

Am J Respir Crit Care Med. 1999; 159:179-187

6.

J. Formosan Med. Assoc. 80; 19-29, 1981, Study on Maximal Expiratory Flow and Volume in Chinese, Min-Chien WU

Customer contact information

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UK CUSTOMERS ONLY For all Sales Order processing for products, training and spare parts, Service and Technical Support enquiries, please contact the following: CareFusion UK 232 Ltd UK Customer Service & Support The Crescent Jays Close Basingstoke RG22 4BS Customer Service Sales Enquiries: Telephone: 01256 388550 Email: [email protected] Factory Repair and Administration Enquiries: Telephone: 01256 388552 Email: [email protected] Technical Support Enquiries: Telephone: 01256 388551 Email: [email protected]

INTERNATIONAL CUSTOMERS ONLY For all Sales Order processing for products and Spare parts, Service and Technical Support enquiries, please contact the following: Carefusion Germany 234 GmbH Customer Service & Support International Leibnizstrasse 7 97204 Hoechberg Germany Customer Service Sales Enquiries: Telephone: 0049 931 4972 670 Email: [email protected] Factory Repair and Administration Enquiries: Telephone: 0049 931 4972 867 Email: [email protected] Technical Support Enquiries: Telephone: 0049 931 4972 127 Email: [email protected]

CareFusion UK 232 Ltd. Quayside Chatham Maritime Kent ME4 4QY U.K.

JDE no. 36-MAN1187 Drg no. 088-30 Issue 1.3 Febuary 2010 © CareFusion 2009

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