GERATHERM Diffustik User manual

Diffustik
(incl. system variant PFTstik)
Serial numbers: xx|8|401|yyy and 2401xxxxx
Instructions for Use
Version: 8
Release date: 16. August 2021
Please read carefully and store in a place which is always accessible for future
consultation!

Version: 8
Release date:16. August 2021
Filename: TDODIF0084R8
Language: English
Affected serial numbers: xx|8|401|yyy and 2401xxxxx
Software version: valid from 1.2.0
Geratherm® Respiratory GmbH
Kasernenstraße 4
97688 Bad Kissingen, GERMANY
Tel.: [phone]
Fax: [phone]
[e-mail]
www.geratherm-respiratory.com
EUDAMED SRN:
DE-MF-000006818
© Geratherm® Respiratory GmbH
0494

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Version: 8 | Release date: 16. August 2021
Page 3
Table of Contents
1General Information ...............................................................6
1.1 Abbreviations.................................................................................. 7
1.2 Explanations................................................................................... 7
1.3 Symbols ......................................................................................... 9
1.4 Copyright...................................................................................... 12
1.5 Limitation of Liability ..................................................................... 12
2Conditions of Use ................................................................13
2.1 Intended Purpose......................................................................... 13
2.1.1 Indication...................................................................................... 15
2.1.2 Contraindication and Side Effect................................................... 16
2.1.2.1 Contraindications.......................................................................... 16
2.1.2.2 Side Effects .................................................................................. 17
2.1.3 Definition of the Groups of People ................................................ 18
2.2 Intended Use................................................................................ 19
2.2.1 Original Spare Parts / Accessories / Optional Expansions ............ 21
2.2.1.1 Original Spare Parts / Accessories................................................ 22
2.2.1.2 Optional Expansions..................................................................... 28
2.2.2 Consumable Items / Auxilary Materials ......................................... 29
3Safety in Handling ................................................................31
3.1 General Safety at Work and Personnel Qualification ..................... 33
3.2 The Technical State of Diffustik / Variant PFTstik and System
Construction................................................................................. 34
3.3 Operation / Servicing and Maintenance ........................................ 36
3.4 Electromagnetic Compatibility (EMC) ............................................ 38
3.5 Cleaning and Disinfection ............................................................. 39
4Structure and General Function of Diffustik resp. the Variant
PFTstik .................................................................................40
4.1 Hardware ..................................................................................... 40
4.1.1 Overview of the Complete System of the Diffustik Variant............. 40
4.1.2 Overview of the Complete System of the PFTstik Variant.............. 41
4.1.3 Diffustik / Variant PFTstik.............................................................. 42
4.1.3.1 Height-Adjustable Arm with Flow Measurement / Shutter System
Variant Diffustik............................................................................. 42
4.1.3.2 Height-Adjustable Arm with Flow Measurement / Shutter System
Variant PFTstik ............................................................................. 43
4.1.3.3 Diffustik Device / Connections ...................................................... 44
4.1.3.4 Connection on the Height-Adjustable Arm.................................... 45

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 4
Version: 8 | Release date: 16. August 2021
4.1.3.5 Sensors ........................................................................................ 46
4.1.3.6 Pressure Reducer (optional with Extension „Diffusion Measurement“)
..................................................................................................... 47
4.1.4 System Construction and Electrical Safety ................................... 48
4.1.4.1 Equipment Cart with Isolating Transformer ................................... 50
4.1.4.2 Data Connection .......................................................................... 50
4.2 Technical Protection Measures..................................................... 51
4.3 Software....................................................................................... 51
5Transport Storage and Assembly ........................................52
5.1 Transport to the Location of Use .................................................. 52
5.2 Storage ........................................................................................ 52
5.3 Assembly...................................................................................... 52
6Operation .............................................................................54
6.1 Initial Operating............................................................................. 54
6.2 Recommissioning after Servicing / Cleaning Work ........................ 54
6.2.1 Assembly Flow Measuring System ............................................... 55
6.2.2 Assembly Shutter System............................................................. 58
6.2.3Inserting the Flow Sensor ............................................................. 60
6.2.4 Power Supply and Computer Connection .................................... 61
7Operating Instructions .........................................................63
7.1 Checking for Worn Parts .............................................................. 63
7.2 Switching Diffustik / Variant PFTstik On / Off ................................ 64
7.3 Calibrating Diffustik / Variant PFTstik ............................................ 64
7.4 Setting the Height-Adjustable Arm................................................ 65
7.4.1 Height Adjustment........................................................................ 65
7.4.2 Horizontal Adjustment .................................................................. 66
7.5 Using Diffustik / Variant PFTstik / Performing measurements........ 66
7.6 Exchange of Disposable Products / Disinfection........................... 69
7.6.1 Bacteria- and Virus Filter / Noseclip.............................................. 69
8Servicing / Maintenance ......................................................70
8.1 Duties of the Responsible Organisation ........................................ 70
8.2 Servicing / Maintenance by the User / Operator ........................... 71
8.2.1 Checking / Exchange of Tubes and Cables .................................. 73
8.2.2 Checking / Replacing O-Rings and Sealing Rubbers .................... 73
9Cleaning and Disinfection ....................................................75
9.1 Single Use .................................................................................... 76
9.2 Disinfection................................................................................... 77
9.2.1 Height-Adjustable Arm ................................................................. 79

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Version: 8 | Release date: 16. August 2021
Page 5
9.2.2 Flow Unit ...................................................................................... 79
9.2.3 Ergoflow / Flow Sensor................................................................. 80
9.2.4Shutter System............................................................................. 81
9.2.4.1 Shutter-Cage or Shutter Block ..................................................... 81
9.2.4.2 Shutter-Drive ................................................................................ 82
10 Fault Indication and Repair..................................................83
11 Decommissioning / Disposal ...............................................85
11.1 Expected Service Life ................................................................... 85
11.2 Decommissioning ......................................................................... 85
11.3 Disposal ....................................................................................... 85
11.3.1 Transport Packaging .................................................................... 85
11.3.2 Diffustik / Variant PFTstik.............................................................. 85
11.3.3 Infectious / Contaminated Single Use Items ................................. 86
12 Technical Specifications ......................................................87
12.1 Technical Data.............................................................................. 87
12.2 Installation and Operating Conditions ........................................... 89
12.3 Electrical Safety Concept.............................................................. 90
12.3.1 Variant Diffustik with Medical Device Cart and Isolation Transformer
..................................................................................................... 90
12.3.2 Variant PFTstik with Medical Device Cart and Isolation Transformer91
12.4 Electromagnetic Compatibility / EMC Guidelines .......................... 92
12.4.1 Emitted Interference Guideline and Manufacturer Declaration....... 92
12.4.2 Interference Resistance for all ME Systems Guideline and
Manufacturer Declaration ............................................................. 93
12.4.3 Interference Resistance for Non-Life-Supporting ME Systems
Guideline and Manufacturer Declaration ....................................... 94
12.4.4 Recommended Safety Distances for Non-Life-Supporting ME
Systems ....................................................................................... 97
13 Safety of Product and Material ............................................98
14 Product Labeling / Type Label.............................................99
15 Warranty and Service.........................................................100
15.1 General Conditions..................................................................... 100
15.2 Warranty Exemption ................................................................... 100
15.3 Packaging and Shipping............................................................. 101
16 Authorised Specialist Retail Partner ..................................102
Attachment – Declaration of Conformity............................103

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 6
Version: 8 | Release date: 16. August 2021
Foreword
Thank you for purchasing a medical device from Geratherm®
Respiratory GmbH. Diffustik and the variant PFTstik are a part of
our product family with solutions for cardiopulmonary function
diagnostics which are operated using the common software
platform BLUE CHERRY®. This means that you have the option
of optimising the working processes in your practice using the
networked application of further products from Geratherm®
Respiratory GmbH, and to benefit from the simple use of our
products.
1General Information
All our medical devices are manufactured and tested in
accordance with certified quality standards. This means that
Diffustik and the variant PFTstik fulfills the regulatory
requirements for medical devices (class IIa).
This IFU is a component of the product in accordance with DIN
EN ISO 60601-1. It should make it easier to familiarise yourself
with Diffustik resp. the variant PFTstik, as well as give you
instructions about its intended use and safe operation.
This IFU has been written for healthcare professionals who are
qualified to perform spirometric examinations.
The basic prerequisite for safe working with the Diffustik resp.
the variant PFTstik is to follow all the safety instructions given.
In addition to the notes in this IFU, the local accident prevention
regulations and the national industrial safety regulations apply.
Read this IFU carefully and in its entirety before using Diffustik
resp. the variant PFTstik. For future reference, keep them in
the immediate vicinity of the medical device, ready at hand for
the user / operator and accessible at all times!
Please refer to the separate instructions for use of the
BLUE CHERRY® software platform for pulmonary function
diagnostics.

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Version: 8 | Release date: 16. August 2021
Page 7
If, in spite of careful reading of this IFU, you require more
information, please contact your specialist retail partner on site.
You can obtain the contact details via a form provided by the
manufacturer at www.geratherm-respiratory.com/login/.
1.1 Abbreviations
The following simplified style of writing and abbreviations are
used hereinafter to make this IFU easier to read.
Instructions for Use IFU
Geratherm® Respiratory GmbH Manufacturer
Medical specialist personnel User(s)
Personnel instructed in cleaning /
maintenance work Operator(s)
1.2 Explanations
For the safety of your patients, for your personal safety and to
avoid damage to property, observe the meaning of the following
explanations of symbols. These are divided into hazard levels. If
several severity levels occur at the same time, the warning note
for the highest level is always used.
The safety instructions are presented in accordance with DIN
ISO 3864 following ANSI Z535.4 (American National Standards
Institute).

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 8
Version: 8 | Release date: 16. August 2021
Indicates a directly hazardous situation.
Not observing and not avoiding the situation will lead to
death or severe injuries. The signal word DANGER is
only used for extreme situations.
Indicates a possibly hazardous situation.
Not observing and not avoiding the situation may lead to
death or severe injuries.
Indicates a possibly hazardous situation.
Not observing and not avoiding the situation may lead to
minor or moderate injuries.
Indicates places in the IFU which are relevant to the current
topic but do not present any danger, or which simplify your
handling of the Diffustik resp. the variant PFTstik.
Attention
Not observing this warning information may lead to faults or
malfunctions of the Diffustik resp. the variant PFTstik or may
indicate that something in its environment may be damaged.

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Version: 8 | Release date: 16. August 2021
Page 9
1.3 Symbols
Symbols displayed in this IFU, on the medical device itself and /
or on its packaging are standardised symbols.
Symbol Explanation
Follow the instructions for use!
Applied part from type BF corresponding to
DIN EN 60601-1
The applied part is in direct contact with the patient
(BF: Body Floating). In order to comply with the limit
value for the patient leakage current, the applied part is
insulated from earth.
Only use indoors!
IP20
Protection type (safe environmental conditions)
IP2x: Protection of enclosure against ingress of solid
foreign objects with a diameter greater than or equal to
12.5 mm and access to hazardous parts with finger.
IPx0: No protection of enclosure against harmful ingress
of water.
IP40
Protection type (safe environmental conditions)
IP4x: Protection against penetration of foreign bodies
with a diameter of > 1.0 mm
IPx0: No protection of enclosure against harmful ingress
of water.

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 10
Version: 8 | Release date: 16. August 2021
Symbol Explanation
Do not dispose of the device along with general
household waste!
It must be disposed of in a proper and correct manner
via the specialist retail partner. By marking a device with
this symbol, the manufacturer also declares that he fulfills
all the requirements of the law on the distribution, return
and environmentally friendly disposal of electrical and
electronic devices. (Rechargeable) batteries must be
taken to a central collection point for used batteries or to
the manufacturer.
For single use only!
This symbol does not refer to the Diffustik resp. the
variant PFTstik itself, but to the consumable items used
in connection with it. This is applied to the respective
packaging and must be observed.
Batch number
This symbol identifies the batch or lot code given by the
manufacturer. The code is placed adjacent to the
symbol.
Serial number
This symbol identifies the serial number given by the
manufacturer.
Catalog number
This symbol identifies the catalog number given by the
manufacturer.
Manufacturer
This symbol identifies the manufacturer of a product.
Date of manufacture
This symbol indicates the date on which a product is
manufactured.

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Version: 8 | Release date: 16. August 2021
Page 11
Symbol Explanation
0494
Conformity mark
This symbol indicates conformity with health, safety and
environmental protection standards for products sold
within the European Economic Area (EEA). The
additional four-digit number identifies the Notified Body
involved in the conformity evaluation procedure of this
product. In this case 0494 identifies SLG Prüf- und
Zertifizierungs GmbH as Notified Body.
Caution, non-ionizing electromagnetic radiation
Precautions must be taken to avoid an unexpected
effect of non-ionizing radiation.
Fragile, handle with care
The package contains a product that must be handled
with appropriate care to prevent damage during
transport and storage.
Keep away from rain
The package contains a product that must be protected
from moisture during transport and storage.
Temperature limitation
The product can be safely transported, stored or
operated within the specified temperature range.
Humidity limitation
The product can be safely transported, stored or
operated within the specified humidity range.
Atmospheric pressure limitation
The product can be safely transported, stored or
operated within the permissible atmospheric pressure.

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 12
Version: 8 | Release date: 16. August 2021
1.4 Copyright
The manufacturer reserves all rights to this document and the
information contained therein. No part of this document or the
information contained herein may be reproduced or transmitted
without the written consent of the manufacturer. All information
or brand names of a third party contained in this document are
subject to the copyright of that third party.
1.5 Limitation of Liability
The manufacturer emphasises the creation of accompanying
documents for his products. Despite careful checking, errors or
inaccuracies in this document version cannot be completely
ruled out. The liability of the manufacturer for direct or indirect
damages arising in connection with the present documentation
is excluded to the extent permitted by law. Technical or content
information in this document is subject to change at any time
and without notice. Should any questions arise, please contact
your authorised specialist retailer or the manufacturer directly.

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Version: 8 | Release date: 16. August 2021
Page 13
2Conditions of Use
Any other use of Diffustik resp. the variant PFTstik which is
not described in this IFU is deemed improper use. The
responsible organisation of Diffustik resp. the variant PFTstik
alone is liable for any direct or indirect damage resulting from
not adhering to these conditions. They are then solely
responsible for the fulfillment of the basic requirements of the
medical device and assumes complete product liability for the
whole system.
2.1 Intended Purpose
For the Diffustik variant, the separate IFU
Add-on CO Diffusion is additionally intended for the following
purposes.
The Diffustik resp. the variant PFTstik is a medical electrical
device. As a PC-linked PFT system, it is mainly intended to
determine lung volumes and airway resistances (Rint) in lung
function diagnostics in the clinical sector and by general
practitioners.
Diffustik resp. the variant PFTstik is designed for use in the
mouth, nose, upper throat area, trachea and lungs of the patient
(definition see chap 2.1.3 “Definition of the Groups of People”).
The Diffustik resp. the variant PFTstik and the Flow sensor may
only come into contact with intact skin and mucous membrane.
The standard version of the associated software enables the
Measurement of Spirometry, Flow / Volume, Airway Resistance
(Rint) as well as Pre / Post Examinations and Trend Analysis.
Using Diffustik resp. the variant PFTstik, you can also carry out
the examination stated below.

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 14
Version: 8 | Release date: 16. August 2021
For a detailed description of the option ”CO Diffusion“, please
refer to the separate IFU:
•Add-on CO Diffusion
Examination
Required option
CO Diffusion
Variant Diffustik: Included
Variant PFTstik: Add-on CO Diffusion ( 259149)
MIP / MEP
MIP / MEP ( 250798)
P0.1
MIP / MEP ( 250798)
Breathing Pattern
Analysis
MIP / MEP ( 250798)
You can find more information in:
•IFU Spirometry
for carrying out the examination
•IFU BLUE CHERRY®
for the general operation of the software and carrying out
the examination

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Version: 8 | Release date: 16. August 2021
Page 15
2.1.1 Indication
With Diffustik resp. the variant PFTstik, pulmonary function
examinations can be carried out for diagnosing, monitoring of
process, screening and assessing the severity of pulmonary
diseases. In particular, this includes:
Obstructive diseases
•Complaints such as dyspnea (shortness of breath) or
coughing when at rest as well as under stress
•Bronchial asthma
•Chronic obstructive pulmonary disease (COPD)
•Pulmonary emphysema
Restrictive diseases
•Interstitial lung diseases
•Pulmonary fibrosis
•Impairments of the chest
•Neuromuscular diseases
Allergy diagnosis

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 16
Version: 8 | Release date: 16. August 2021
2.1.2 Contraindication and Side Effect
2.1.2.1 Contraindications
The following contraindications apply to lung function
examinations:
Contraindications Absolute Relative
Patients with a new (< 1 month old)
myocardial infarction
X X
Aneurysm of the ascending aorta
X X
Pulmonary embolism
X X
Tension pneumothorax
X
Acute internal bleeding
X
Recent eye operations
X
Recent thorax / abdominal operations
X
Hemoptysis
X
Acute diarrhea
X
Angina
X
Severe hypertension
(SBP > 200 mmHg, DBP > 120 mmHg)
X
Confusion / dementia
X
Infectious diseases
X
As the transitions between absolute and relative
contraindication can be fluid in the assessment, the assertion
of a physician should be regarded as binding.
(Source: Cooper BG. 2011. An update on contraindications for lung function
testing. Thorax 66:714–723.)

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Version: 8 | Release date: 16. August 2021
Page 17
2.1.2.2 Side Effects
If there are no contraindications and the examination is carried
out in accordance with the descriptions in the instructions for
use, side effects rarely occur in pulmonary function
examinations. These can be described as follows:
Side effect / Frequency Rules of conduct
Dizziness, syncope /
on a case-by-case basis
Examinations should preferably be
performed in a sitting position and the
patient should be permanently
observed during the examination.
Spontaneous pneumomediastinum,
pneumopericardium and
subcutaneous emphysema in
spirometry /
in extremely rare cases
Investigate any
persistent dyspnea that
occurs after the examination.

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 18
Version: 8 | Release date: 16. August 2021
2.1.3 Definition of the Groups of People
Groups of people named in this IFU are defined as follows:
Manufacturer
specifies all measures to ensure the safe and proper handling
and application of Diffustik resp. the variant PFTstik. They are
responsible for instructing the user in relation to this via the
corresponding specialist retail partner.
Responsible Organisation
is any natural or legal person who is responsible for the
operation of the health institution where Diffustik resp. the variant
PFTstik is used by their employees (users / operators).
User
is a medically trained specialist who is familiar with spirometry
examinations, who uses Diffustik resp. the variant PFTstik on the
patient after verifiable instruction by the responsible organisation
and / or is responsible for rectifying faults to the Diffustik resp.
the variant PFTstik, as well as its calibration.
Users must be aware of the clinical meaning and, for example,
be a physician, physician’s assistant, assistant or trained
maintenance personnel with basic electrical or mechanical
training. The user is able to identify, assess and, in the best
case, to avoid possible hazards when using Diffustik resp. the
variant PFTstik.
Trainee medical specialists must also be supervised in addition
to receiving training in how to use Diffustik resp. the variant
PFTstik.
Operator
is a person who has received instruction on cleaning Diffustik
resp. the variant PFTstik by a medically trained specialist.
Patient
is a person undergoing medical treatment (check-up, initial
diagnosis as well as progress / treatment monitoring) to assess
their pulmonary function. The persons can be adults without an
age limitation as well as children form 4 years of age.
A requirement for carrying out the examination is the ability to
follow the instructions of the user.

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Version: 8 | Release date: 16. August 2021
Page 19
2.2 Intended Use
Diffustik resp. the variant PFTstik can be operated independently
as a non-stationary device or in combination with all other
Geratherm® Respiratory GmbH products via the universal
software BLUE CHERRY®.
(See chap. 4.1.4 “System Construction and Electrical Safety”)
In all cases, the Diffustik resp. the variant PFTstik is only
intended for use in closed, pleasantly temperature-controlled
(19 °C - 25 °C) rooms in a clinical area.
In the respective room, there must be neither flammable or
explosive gases, nor magnetic fields (e.g. MRI).
With the Diffustik variant or the PFTstik variant in combination
with the Add-on CO Diffusion extension, the room must always
be well ventilated, to protect users and third parties from
continuous exposure to harmful carbon monoxide (CO).
The following applies in general: The installation of Diffustik resp.
the variant PFTstik is only deemed safe and in line with intended
use when this is carried out in accordance with the details in
chap. 12.2 “Installation and Operating Conditions”.
Attention
The Diffustik resp. the variant PFTstik must be operated exclusively
with the equipment cart approved by Geratherm® Respiratory (REF
10.905). The equipment cart provides electrical isolation from the
power supply network. All necessary peripheral devices such as
computer, printer and monitor may only be connected to the power
supply network via the equipment cart. See also. chap. 4.1.4 "System
Construction and Electrical Safety". If you have any questions, please
contact your local specialist dealer.

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 20
Version: 8 | Release date: 16. August 2021
The responsible organisation must ensure that only medically
trained specialist personnel (see chap. 2.1.3 “Definition of the
Groups of People”) operates Diffustik resp. the variant PFTstik.
Personnel must demonstrably have been given training in the
function of Diffustik resp. the variant PFTstik. This also includes a
complete study of this IFU.
The manufacturer has determined the expected service life (see
Chapter 11.1 "Expected Service Life") and the maintenance
work required for this (see chap. 8 "Servicing / Maintenance").
The Diffustik resp. the variant PFTstik may only be used for the
duration of its service life if the specifications are observed.
Any changes to Diffustik resp. the variant PFTstik, in particular
unauthorised modifications, are prohibited.
The Diffustik resp. the variant PFTstik is not intended for the
control of vital physiological parameters where the nature of the
change could lead to immediate danger to the patient, e.g.
changes in heart function, respiration or central nervous system
activity.
Any other than the described use is deemed improper use.
The responsible organisation of Diffustik resp. the variant PFTstik
alone is liable for any damage resulting from not adhering to
these conditions.
Intended use also includes complying with all further information
and instructions in this IFU, without exception.
Attention
Electromagnetic compatibility (EMC) in accordance with
DIN EN 60601-1-2:2016-05; VDE 0750-1-2:2016-05; IEC 60601-1-
2:2014. See chap. 12.4 “Electromagnetic Compatibility / EMC
Guidelines”. Diffustik resp. the variant PFTstik is suitable for use in all
institutions including those in residential areas and those which are
directly connected to the public supply network which also supplies
buildings used for residential purposes.