Care Fusion PulmoLife User manual

English 1
PulmoLife
Instructions for use
Moded’emploi
Bedienungsanleitung
Instrucciones de uso
Gebruiksaanwijzing
Istruzioni per l’uso
Instruções de utilização
Инструкция по эксплуатации
参考

Instructions for use
English
Page 1
Moded’emploi
Français
Page 17
Bedienungsanleitung
Deutsch
Page 33
Instrucciones de uso
Español
Page 50
Gebruiksaanwijzing
Nederlands
Page 66
Istruzioni per l’uso
Italiano
Page 82
Instruções de utilização
Português
Page 98
Инструкция по эксплуатации
Русский
Page 115
使用说明
中文
Page 134
References
Références
Hinweise
Bibliografía
Referenties
Bibliografia
Referências
Литература
参考
Page 150

English 1
TurbineHousing
Scroll Up
Scroll Down
Turbine
SwirlPlate
On/Off
Enter (New Blow)
I Introduction - English
ABOUT PULMOLIFE
The PulmoLife 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
BEFORE USING YOUR PULMOLIFE YOU MUST
REMOVE THE BATTERY CONNECTION TAB
CONTRAINDICATIONS
 Acute disorder affecting test performance ( e.g. Vomittig,
nausea, vertigo)
 Recent eye surgery (increases in intraocular presurre
spirometry.
 Oral or facial pain exacerbated by mouthpiece
 Recentmyocardial infarction
PLEASE NOTE: Extensive exhalation might lead to syncope

2 English
WARNINGS AND CAUTIONS
The following terms are used as follows in this manual
CAUTION: Possibility of injury or serious damage
WARNING: Conditions or practices that could result in personal
injury
PLEASE NOTE: Important information for avoiding damage to the
instrument or facilitating operation of the instrument.
CAUTION: Read the manual before use
CAUTION: For batteries, do not attempt to charge,
connect improperly, or dispose of in fire as there is
possibility of leakage or explosion. Follow manufacturer’s
recommendation for proper disposal.
WARNING: The instrument is not suitable for use in the
presence of explosive or flammable gases, flammable
anaesthetic mixtures or in oxygen rich environments.
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.
PLEASE NOTE: The product you have
purchased should not be disposed of as
unsorted waste. Please utilise your local WEEE
collection facilities for the disposal of this
product.
PLEASE NOTE: Degree of protection against Ingress of
Water is IPX0.
INTENDED USE
The intended use of PulmoLife is to quickly and easily screens
smokers for early detection of Chronic Obstructive Pulmonary
Disease (COPD). The effects of COPD in smokers are normally
detectable from the age of 35.
The measurement taken from the unit 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

English 3
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
keys to change values and the Enter key to accept and proceed.
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.

4 English
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 patient’s FEV1 %predicted is above 100% of
predicted then their estimated ‘Lung Age’ would be lower than their
chronological age.
Use the scrolling Up / Down keys to move back and
forth between both results screens.
Press Enter 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
Disinfection of contaminated parts is only effective after having them
carefully pre-cleaned. CareFusion recommend the tested solution of
PeraSafe sterilizing powder (36-SSC5000A) for pre-cleaning and
disinfection. If a different solution is used, please follow the given
manufacturer’s instructions.
It is recommended that - One-Way Valve Disposable Mouthpieces
(36-SST1000) are used with the PulmoLfe unit. With the use of a new
disposable mouthpiece for each patient, the transducer and must be
sterilized once a week.
CAUTION: Switch off the device before cleaning.
The external housing of the PulmoLife may be wiped with sterile
wipes or a damp cloth that has been immersed in a cold sterilising
solution, when required
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.
To sterilise, immerse the turbine in a cold-water solution (e.g.
PeraSafe) for a period not exceeding 10 minutes.

English 5
PLEASE NOTE: Do not use alcohol or chloride based solutions.
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.
CAUTION: Do not attempt to wash or immerse the Pulmolife
transducer housing in water or cleaning fluid, as there are electronic
components inside that will be permanently damaged.
PLEASE NOTE: Used cardboard mouthpieces must be disposed off
immediately after each use.
If there are changes on the material surfaces (cracks, brittleness) the
respective parts must be disposed off.
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. (36-SM2125). We recommend that
a calibration check is performed after the transducer has been
replaced or after it has been removed for cleaning.
To check the calibration hold down the On and Scrolling Up
keys together, and only release when ‘Ch’ is displayed.
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).
PLEASE NOTE: It is recommended that a used transducer is
disinfected prior to a calibration check or a MicroGard filter is used
during the procedure.

6 English
SERVICE
This unit requires no routine servicing.
BATTERY
The PulmoLife is powered by a 3 Volt Lithium coin cell accessed via a
slide cover on the rear of the instrument. 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.
For access to the battery first remove the screw and then the battery
cover by sliding sideways as indicated
Disassembly
Prise out the old coin cell using a
suitable, non-metallic implement
Assembly
Replace the battery paying
particular attention to its
orientation. The part number
etched on its outer face should be
uppermost and visible when the
battery is inserted.
Press until clicked into place
Slide the battery cover back into place, insert the screw and tighten it
hand-tight.
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 NOTE: Please remove the battery if the meter is likely to be
unused for some time.
CAUTION: Do not open the battery cover when the device is turned on.
CAUTION: The patient should not be allowed to remove the battery
cover.
CAUTION: The operator should not touch the contacts of the battery
and the patient at the same time.
PLEASE NOTE: Dispose of the waste battery in accordance with EU
Waste Battery Regulations.