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.

English 7
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
3 Asian (Chinese)6
When the desired number is selected press the Enter key to
accept and save that predicted value set as default.
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.
TROUBLE SHOOTING INFORMATION
Should you encounter problems operating your Pulmolife unit, please
consult the table below:
Problem
Possible
Cause
Solution
Does not register a blow
Turbine
incorrectly
fitted
Ensure turbine is tightly
pushed into the unit.
Unit does not turn on or
Solid “bAt” indicator is
displayed, while unit
beeps three times and
powers itself down after
5 seconds
Battery is
exhausted
Replace battery
Calibration Check failed
or cannot be completed
There are
leaks in the
syringe or
connections
Check the syringe and
connections for leaks
Turbine
may be
faulty
Repeat calibration
procedure, if problem still
persists, replace turbine
Shaft of the
syringe
being
pushed
down
The syringe should be
emptied and filled with one
smooth stroke, avoid
pushing down on the shaft
or banging at the end of
each manoeuver.

8 English
SAFETY DESIGNATION PER IEC 60601-1
Type of protection against
electrical shock
Internally powered Equipment
Degree of protection
against electrical shock
Type B applied part
Power Equipment
Battery type:
3V Lithium Ion Coin Cell Battery
(model no CR-2450)
Degree of Electrical
connection between
equipment and Patient
Equipment designed as non-
electrical connection to the patient.
Degree of mobility
Transportable
Mode of operation
Continuous
Classifications according to
IEC 60601-1
Applied part, type B
WARNING: No modification of this equipment is allowed.
WARNING: The user must not touch any voltage-carrying parts and the
patient at the same time.

English 9
ELECTROMAGNETIC COMPATIBILITY (EMC)
WARNING: use of portable phones or other radio frequency (RF)
emitting equipment near the system may cause unexpected or
adverse operation
The Pulmolife has been tested to EN60601-1-2:2007, regarding its ability
to operate in an environment containing other electrical/electronic
equipment (including other medical devices).
The purpose of this testing is to ensure that the Pulmolife is not likely to
adversely affect the normal operation of other such equipment and that
other such equipment is not likely to adversely affect the normal operation
of the Pulmolife.
Despite the testing of the Pulmolife that has been undertaken, normal
operation of the Pulmolife can be affected by other electrical/electronic
equipment and portable and mobile RF communications equipment.
As the Pulmolife is medical equipment, special precautions are needed
regarding EMC (electromagnetic compatibility).
It is important that the Pulmolife is configured and installed/put into
service, in accordance with the instructions/guidance provided herein and
is used only in the configuration as supplied.
Changes or modifications to the Pulmolife may result in increased
emissions or decreased immunity of the Pulmolife in relation to EMC
performance.
The Pulmolife should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use with other equipment is necessary,
the Pulmolife and the other equipment should be observed/ monitored, to
verify normal operation in the configuration in which it will be used.
For the purposes of EN60601-1-2 the Pulmolife has an essential
performance (the Pulmolife must not begin to measure unintentionally
during a test and should pass a post test 3 litre calibration syringe
measurement).

10 English
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Pulmolife is intended for use in the electromagnetic environment
specified below. The customer or the user of the Pulmolife should assure that
it is used in such an environment.
Immunity Test
IEC 60601 test
level
Compliance
Level
Electromagneti
c Enviroment -
Guidance
Electrostatic
discharge (ESD)
IEC61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be
wood, concrete
or ceramic tile. If
floors are
covered with
synthetic
material, the
relative humidity
should be at
least 30%.
Electrical fast
transient / burst
IEC61000-4-4
± 2 kV for power
supply lines
± 1 kV for input /
output lines
Not Applicable
(Battery
Powered) and
No Cables
Mains power
quality should
be that of a
typical
commercial or
hospital
environment.
Surge
IEC61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Not Applicable
(Battery
Powered)
Mains power
quality should
be that of a
typical
commercial or
hospital
environment.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Pulmolife is intended for use in the electromagnetic environment
specified below. The customer or the user of the Pulmolife should assure that
it is used in such an environment.
Emission Test
Compliance
Electromagnetic Enviroment -
Guidance
RF emissions
CISPR 11
Group 1
The Pulmolife 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.
RF emissions
CISPR 11
Group B
The Pulmolife is suitable for use
in all establishments, including
domestic establishments and
those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Harmonic
emissions
IEC61000-3-2
Not Applicable
(battery powered)
Voltage fluctuatuins
/ flicker emissions
IEC61000-3-3
Not Applicable
(battery powered)

English 11
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Pulmolife is intended for use in the electromagnetic environment
specified below. The customer or the user of the Pulmolife should assure that
it is used in such an environment.
Immunity Test
IEC 60601 test
level
Compliance
Level
Electromagneti
c Enviroment -
Guidance
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC61000-4-11
<5% UT
(>95 % dip in UT)
For 0.5 cycle
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 s
Not Applicable
(Battery
Powered)
Mains power
quality should
be that of a
typical
commercial or
hospital
environment. If
the user of the
Pulmolife
requires
continued
operation during
power mains
interruptions, it
is recommended
that the
Pulmolife be
powered from
an
uninterruptable
power supply or
a battery.
Power frequency
(50/60Hz)
Magnetic field
IEC61000-4-8
3 A/m
3 A/m
If incorrect
operation
occurs, it may
be necessary to
position the
Pulmolife further
from sources of
power frequency
magnetic fields
or to install
magnetic
shielding. The
power frequency
magnetic field
should be
measured in the
intended
installation
location to
assure that it is
sufficiently low.
NOTE UT is the a.c. mains voltage prior to application of the test level.

12 English
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Pulmolife is intended for use in the electromagnetic environment
specified below. The customer or the user of the Pulmolife should assure
that it is used in such an environment.
Immunity
Test
IEC 60601
test level
Complianc
e Level
Electromagnetic
Enviroment -Guidance
Conducted
RF
IEC61000-4-
6
Radiated RF
IEC61000-4-
3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
Not
Applicable
(Battery
Powered
and No
Cables)
3 V/m
Portable and mobile RF
communications
equipment should be used
no closer to any part of the
Pulmolife, including any
cables, than the
recommended separation
distance calculated from
the equation applicable to
the frequency of the
transmitter.
Recommended
separation distance (d)
d = 1.2√P
d = 1.2√P 80 MHz
to 800 MHz
d = 2.3√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).
Fields strengths from fixed
RF transmitters, as
determined by an
electromagnetic site
survey,a should be less
than the compliance level
in each frequency range.b
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects
and people.

English 13
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 Pulmolife is used exceeds
the applicable RF compliance level above, the Pulmolife should be observed
to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orientating or relocating the
Pulmolife.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.
Recommended separation distances between portable and mobile RF
communications equipment and the Pulmolife
The pulmolife is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the
pulmolife can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications
equipment (transmitters) and the pulmolifw as recommended below,
according to the maximum output power of the communications equipment.
Rated Maximum
Output Power of
Transmitter in Watts
(W)
Separation Distance in Meters (m) according to
Frequency of Transmitter
150 KHz to
80 MHz
d = 1.2√P
80 MHz to
800 MHz
d = 1.2√P
800 MHz
to 2.5 GHz
d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23.3
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (m) can be estimated 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.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures objects
and people

14 English
SPECIFICATIONS
Measurement
Forced Expiratory Volume in 1 second
(FEV1)
Forced Expiratory volume in 1 second as a
percentage of predicted (%FEV1)
Lung Age
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
Recommendations
Flow Range:
0-14 L/s As per ATS/ERS
recommendations
Predicted Values
1) ECCS
2) NHANES III
3) Asian (Chinese)
Display:
Custom Liquid Crystal
Power Supply:
3V Lithium Ion Coin Cell Battery (model
noCR-2450)
Dimensions:
131 x 59 x 38mm
Weight
Unit only: 96g
Unit complete with accessories: 260g
Operating Temperature:
0°C to +40°C
Operating Humidity:
30% to 90% RH
Storage & Transport
Temperature:
-20°C to + 70°C
Storage & Transport
Humidity:
10% to 90% RH

English 15
ACCESSORIES
Adult disposable mouthpieces with one-
way valve(Box of 500)
36-SST1000
PeraSafe Sterilizing Solution 81g
(to make up 5 litres of solution)
36-SSC5000A
Pouch
36-CAS1048
Replacement Turbine
36-TDX1050
3 Litre Calibration Syringe
36-SM2125
Calibration syringe adapter
861427
For further information or to place an order for Disposables/ Supporting
products please contact CAREFUSION, your local distributor or view our
website www.carefusion.com/micromedical
NOTE: USE ONLY CAREFUSION ACCESSORIES
Note: Information in this manual is subject to change without notice and
does not represent commitment on the part of CareFusion 232 UK Ltd.
No part of this manual may be reproduced or transmitted in any form or
by any means, electronic or mechanical, including photocopying and
recording for any purpose without the written permission of CareFusion
232 UK Ltd.

16 English
SYMBOLS
Type B device
0086
In accordance with Directive 93/42/EEC
Disposal in compliance with WEEE
Consult the instructions for use
Caution: Consult the accompanying
documents
Date of Manufacture
Manufacturer
Serial number
Direct current
Single patient use
Federal U.S. law restricts this device to
sale by or on the order of a physician. (Rx
only)
Medical Device listing mark for US and
Canada by SGS Testing Services
recognised by the American Occupational
Safety and Health for electrical safety and
compliance.