Vitalograph Compact User Manual

4Page
ENG
DT_0006 Issue 17
A Global Leader in Respiratory Solutions
of 28
1. Indications for Use
The Vitalograph Compact is a medical workstation which measures subject
respiratory parameters and is capable of centralising data from external cardio-
pulmonary related testing devices. It is intended for use by trained healthcare
professionals in a variety of professional healthcare environments, e.g. primary
care, hospitals, clinics and mobile clinics including occupational health
settings. The device is designed for use on adult and paediatric patients from
the age of 5 years.
Patients below the age of 5 years can be tested providing they can cooperate
with the test instructions from the healthcare professional. The device
functionality includes integrated spirometry and related pulmonary function
testing including respiratory muscle strength assessments.
Note: The measurements obtained from a lung function test form part of the
various ndings of a physician in the detection, diagnosis and control of chest
diseases.
Apart from this instruction manual, there are no other training requirements for
the healthcare professional
2. Contraindications, Warnings, Precautions and Adverse
Reactions
1. Nomodicationofthisequipmentisallowed.Anyunauthorisedchanges
to the Vitalograph Compact device may compromise product safety and/or
data and as such Vitalograph cannot be held responsible and the device will
no longer be supported.
2. Any changes to the operating system or additional unapproved installations
must be validated by the end user.
3. The Compact is not designed as a sterile device. Always follow the
safety guidelines given by the manufacturer of cleaning and disinfectant
chemicals.
4. Vitalograph intends that a new Bacterial Viral Filter (BVF
TM
) be used for every
subjecttopreventcrosscontamination.UsinganewBVFprovidesasignicant
level of protection of the subject, the device and the user against cross
contamination during spirometry manoeuvres. A BVF is for single use only.
5. Spirometry is a valuable tool that provides important information to
clinicianswhichisusedtogetherwithotherphysicalndings,symptoms,
and history to reach a diagnosis (ATS/ERS 2019).
6. WhenusingtheCompactensurethattheowheadconnectingtubeisnot
pinched or trapped as spirometry results may appear to be inverted.
7. Take care not to block the mouthpiece with tongue or teeth during testing. A
‘spitting’ action or cough will give false readings.

Vitalograph Compact Specifications

General

Brand	Vitalograph
Model	Compact
Category	Medical Equipment
Language	English