Vitalograph asma-1 4000 User manual

asma-1
Child
Guide for Healthcare
Professionals

Testing Subject
2 Blow 3 times
1 Insert mouthpiece and D switch on
3 C View values for parameters FEV.₅,
FEV.₇₅, FEV₁ and PEF
= Bad blow

4 Best blow
Testing Subject
Blow 3 times
PEF +/- 5%; FEV₁ +/- 3%
Insert mouthpiece and D switch on
C View values for parameters FEV.₅,
FEV.₇₅, FEV₁ and PEF
EN ISO 23747:2009
Specifies accuracy: ± 10% PEF
Resistance to flow: < 0.35 kPa/L/s
Vitalograph Childrens
Respiratory Monitor
Accuracy: ± 5% PEF
± 3% FEV₁, .₅,.₇₅
Resistance to flow: < 0.15kPa/L/s
= Bad blow

Review History
2 E Hold for 3 seconds
1 D Switch on
4 E Return
3 Bor C Review history
H www.vitalograph.co.uk I

Review History
Delete History
2 C+ E Hold for 10 seconds
1 D Switch on
H www.vitalograph.co.uk I
Cleaning and Disinfecting:
The outer surfaces should be
cleaned every week, more often if
necessary. The use of an ordinary
alcohol wipe is recommended,
with special attention to the
mouthpiece area.

Regulatory
Notices
Warnings and Advisory Notices:
Note: Please read all this information before
using this Vitalograph device. A full set of
instructions, including cleaning instructions, is
available at www.vitalograph.co.uk.
• This Vitalograph device is intended to
measure lung function, primarily for
single patient use at home under medical
supervision or for use in clinic, where
SafeTway or Bacterial Viral Filter disposable
mouthpieces must be used.
• Take care not to block the mouthpiece with
the tongue or teeth. A ‘spitting’ action or
coughing will give false readings.
• If used at home symptoms must take
precedence over device measurements*.
• If the device is used for longer than its
specified life, the accuracy of the device
may deteriorate.

• Before use, ensure that the batteries do
not exceed their shelf life, as indicated
on the batteries.
• Store in a clean dry place.
• Cleaning & disinfecting: The outer
surfaces should be cleaned every week,
more often if necessary. The use of an
ordinary alcohol wipe is recommended,
with special attention to the
mouthpiece area.
* If the patient at home thinks that the device
is not reading correctly, they must advise the
healthcare professional immediately. Medical
facilities may use a precision syringe to check
the accuracy of this device.
The device must be taken to separate
collection at the product end-of-life.
Do not dispose of these products as
unsorted municipal waste.
F

Warranty:
Your Vitalograph device is guaranteed for
one year*. Replace if it is faulty, otherwise
replace the unit every three years.
* Excepting accidental / transit damage or
inappropriate use of the device.
FDA Notice:
Caution: Federal Law restricts this device to
sale by, or on the order of a physician.
CE Notice:
Marking by the symbol l indicates
compliance of this device to the Medical
Devices Directive of the European
Community. Such marking is indicative that
the Vitalograph device meets or exceeds
the referenced technical standards. The
Vitalograph 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.
The Vitalograph device is battery operated
and 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. The
Vitalograph device is intended for use in
the electromagnetic environment specified
below. The customer or the user of the
system should assure that it is used in such
an environment.
• Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
• Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
• Interference may occur in the vicinity of
equipment marked with the following
symbol - G.

Technical Specifications
Material: PC/ABS
Accuracy:
Better than ± 3% (FEV₁ & FEV₆), ± 10% (PEF)
Flow Impedance (as applicable):
Better than 0.15kPa/L/s at 14L/s
Measurement Range:
PEF: 25 - 840 L/min BTPS
FEV0.5: 0 - 9.99 L BTPS
FEV0.75: 0 - 9.99 L BTPS
FEV1: 0 - 9.99 L BTPS
Safety & Performance Standards:
EN ISO 23747:2009, ISO 26782:2009, ATS/ERS
Guidelines 2005
Electromagnetic emissions:
CISPR 11 Group 1 (battery operated)
Electromagnetic immunity:
IEC 61000-4-2, IEC 61000-4-3 (battery
operated)
Sensor: Stator/rotor
Power Supply: AAA batteries
Operating Temperature: 17 – 37°C

Recommended separation
distances between portable
and mobile RF communication
equipment and the system
The Vitalograph device is intended for
use in an electromagnetic environment
in which radiated RF disturbances are
controlled. The customer or the user of the
system can help prevent electromagnetic
interference by maintaining a minimum
distance between portable and mobile RF
communications equipment (transmitters
and the system as recommended below,
according to the maximum output power of
the communications equipment.
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.

Rated maximum
output power of
transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = 1.2√P
80MHz to 800MHz
d = 1.2√P
800 MHz to 2.5GHz
d = 2.3√P
0.01 0.1m 0.1m 0.2m
0.1 0.4m 0.4m 0.7m
11.2m 1.2m 2.3m
10 3.7m 3.7m 7.4m
100 11.7m 11.7m 23.3m
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.

Declaration of Conformity
Product: Vitalograph Model 4000
Vitalograph hereby ensures and declares
that the above product associated with this
user manual, is designed and manufactured
in accordance with the following QMS
regulations and standards:
• European Medical Devices Directive
{MDD} 93/42/EEC. This device, classified
as 2a as per Annex IX of MDD 93/42/ EEC,
meets the following provisions of Annex
II of the Medical Devices Directive as per
Article 11, section 3a, excluding point 4
of Annex II. This device complies with the
EMC Directive 2004/108/EC, conformance
demonstrated by following standard EN
60601-1-2:2007. Equipment classification:
Residential.
l

• Canadian Medical Device Regulation
{CMDR}.
• FDA Quality System Regulation {QSR} 21
CFR 820.
• EN ISO 13485: 2003. Medical devices.
Quality management systems.
Requirements for regulatory purposes.
Certifying Body {for 93/42/EEC and CMDR}:
British Standards Institute {BSI}.
Certificate Nos. CE 00772, MD 82182,
FM 83550.
Signed on behalf of
Vitalograph (Ireland) Ltd.
B. R. Garbe. Group Managing Director

UK Sales Vitalograph Ltd.
Maids Moreton Buckingham MK18 1SW England
Tel: [phone] Fax: [phone]
e-mail: [e-mail]
www.vitalograph.co.uk
Export Sales Vitalograph Ltd.
Maids Moreton Buckingham MK18 1SW England
Tel: [phone] Fax: [phone]
e-mail: [e-mail]
www.vitalograph.eu
Vitalograph GmbH
Rellinger Straße 64a 20257 Hamburg Germany
Tel: [phone] Fax: [phone]
e-mail: [e-mail]
www.vitalograph.de
Vitalograph Inc.
13310 West 99th Street Lenexa Kansas 66215 USA
Toll Free: 800 2556626
Tel: [phone] Fax: [phone]
e-mail: [e-mail]
www.vitalograph.com
Vitalograph (Ireland) Ltd.
Gort Road Business Park Ennis Co Clare Ireland
Tel: [phone] Fax: [phone]
e-mail: [e-mail]
www.vitalograph.ie
Vitalograph® and asma-1™ are trademarks or
registered trademarks of Vitalograph Ltd.
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