Medela Thopaz+ User manual

Cardiothoracic drainage
Thopaz+
™
EN Instructions for use
DE Gebrauchsanweisung
FR Mode d’emploi
IT Istruzioni per l’uso
NL Gebruiksaanwijzing
SV Bruksanvisning
ES Instrucciones de uso
PT Instruções de utilização

EN
Thopaz University | 3
Thopaz+University
At the web address below you will find short how-to-use videos, research findings and user
guide downloads for Thopaz+that relate to your specific hospital role.
Thopaz+University is a mobile website designed to support you. Within two clicks you can
locate the specific information you need. Each video lasts no longer than 60 seconds and
includes text bullet points and voice commentary.
Thopaz+University can be found at www.medela-university.com or you can access it through
www.medela.com via the “Education” tab. It is available on all formats including desktop,
smartphone and tablet. We recommend saving Thopaz+University as a shortcut on desktop,
smartphone and tablets for even quicker access.
www.medela-university.com

4 | Table of Contents
Table of Contents
Congratulations .......................................................................................................................... 6
1Warnings and safety instructions ..................................................................................... 7
Safety instructions................................................................................................................10
2Power supply and battery operation................................................................................11
Backup battery ....................................................................................................................11
Charge battery .....................................................................................................................11
Battery low...........................................................................................................................11
Battery empty ......................................................................................................................12
3Description..........................................................................................................................13
Introduction..........................................................................................................................13
Intended use/indications .....................................................................................................13
Contraindications .................................................................................................................13
Intended user.......................................................................................................................13
Intended patient population .................................................................................................13
Important note .....................................................................................................................13
Service life............................................................................................................................13
4Overview .............................................................................................................................14
Main elements of Thopaz+.............................................................................................14
Display .................................................................................................................................15
How to activate a button......................................................................................................15
Tubings.................................................................................................................................16
Canisters..............................................................................................................................17
5Additional information .......................................................................................................18
Definition of vacuum.............................................................................................................18
Regulated pressure..............................................................................................................18
Safety pressure limit.............................................................................................................18
Tube flushing........................................................................................................................18
Safety chamber in canister ..................................................................................................18
Fluid measurement...............................................................................................................18
Overflow protection/bacteria filter .......................................................................................19
Light sensor .........................................................................................................................19
6Installation.......................................................................................................................... 20
Check initial delivery............................................................................................................ 20
Initial startup.........................................................................................................................21
7Preparation for use/operating instructions .................................................................... 23
Checks before use...............................................................................................................23
Connect tubing ....................................................................................................................23
Snap in canister ...................................................................................................................24
Using 2l canister ..................................................................................................................24
Switch Thopaz+on ..............................................................................................................25
Carry out functional check...................................................................................................26

EN
Table of Contents | 5
Check therapy progress.......................................................................................................28
Main display .........................................................................................................................28
History................................................................................................................................. 29
Catheter check.....................................................................................................................31
Switching Thopaz+off ........................................................................................................ 32
Transfering data to PC with ThopEasy................................................................................ 33
8Replace canister................................................................................................................ 34
Canister with solidifier: activation of the solidification process............................................ 35
9Changing pressure during operation .............................................................................. 36
Physiological pressure ........................................................................................................ 36
10 Changing settings ............................................................................................................. 37
Factory settings....................................................................................................................37
Change settings.................................................................................................................. 38
Save a changed parameter as the new standard ............................................................... 38
11 Taking a drainage sample ................................................................................................ 39
12 Troubleshooting and alarms ........................................................................................... 40
Description.......................................................................................................................... 40
13 General cleaning guidelines............................................................................................. 42
General notes.......................................................................................................................42
Disposables ........................................................................................................................ 43
14 Warranty, maintenance and checks................................................................................ 44
Warranty.............................................................................................................................. 44
Maintenance........................................................................................................................ 44
Routine Check .................................................................................................................... 44
Instructions for FPT test...................................................................................................... 44
Safety Check....................................................................................................................... 45
15 Disposal ............................................................................................................................ 46
16 Accessories ....................................................................................................................... 46
17 Technical specifications ....................................................................................................47
18 Signs and symbols............................................................................................................ 48
19 Technical documentation ............................................................................................... 390
Appendix A.............................................................................................................................. 395
Appendix B.............................................................................................................................. 397

6 | Congratulations
Congratulations
With Thopaz+ , you have acquired an innovative digital chest drainage system that sets new stan-
dards in therapy and chest drainage management.
Thopaz+ has an electronic measuring and monitoring system with optical and acoustic status
indications. The device is a dry system, which means no fluids are necessary for operation.
Important information regarding the course of therapy is indicated digitally and graphically on the
display. Upon completion of therapy, it can be transferred to a PC.
The handy size, the extreme quietness of operation and the light sensor regulating the brightness
of the screen are very pleasant for the patient as well as those in the vicinity.

EN
Warnings and safety instructions | 7
Thopaz+is approved exclusively for the use as described in these instructions for use. Medela
can only guarantee the safe functioning of the system when Thopaz+is used in combination
with the original Thopaz+accessories (canisters, tubings, carrying strap, mains adapter, docking
station – see chapter 16 – Accessories/Appendix A).
Thopaz+is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 and can be
used in the vicinity of other EMC-tested devices that fulfil the requirements as outlined in the
IEC 60601-1-2 standard. Untested HF sources, radio networks or the like can impair the function
of the device and should not be operated in the vicinity of Thopaz+.
Additional equipment connected to medical electrical equipment must comply with the respec-
tive IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all con-
figurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1
or clause 16 of the 3rd Ed of IEC 60601-1, respectively). Anybody connecting additional equip-
ment to medical electrical equipment configures a medical system and is therefore responsible
that the system complies with the requirements for medical electrical systems. Attention is
drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt,
consult your local Medela customer service representative or your technical service department.
Please read and observe these warning and safety instructions before operation. These
instructions for use must be kept with the device for later reference.
Please note that these Instructions for use are a general guide for the use of the product.
Medical matters must be addressed by a physician.
Medela considers itself only responsible for the effect on BASIC SAFETY, reliability and
performance of Thopaz+if it is used in accordance with the Instructions for use.
Subject to change.
Indicates a potentially hazardous situation which, if not avoided, could result in death or
serious injury.
Indicates a potentially hazardous situation which, if not avoided, could result in minor or
moderate injury.
Indicating useful information about the safe use of the device.
WARNINGS
CAUTIONS
Safety related tip
1 Warnings and safety instructions

8 | Warnings and safety instructions
WARNINGS
– «Pressure» generally implies «negative pressure»
– Consult this manual prior to use.
– Data transfer via USB is not allowed during therapy.
– After each use, the parts that have been in contact with aspirated secretions are to be
cleaned and disinfected or disposed.
– Before cleaning the device, pull the plug out of the fixed mains socket.
– Thopaz+was validated in combination with the accessories listed in Appendix A.
For a correct and safe operation use Thopaz+with these accessories only.
Further information is supplied with the individual accessory.
– Do not use Thopaz+in MRT (Magnetic Resonance Tomography).
– Do not dry Thopaz+with microwaves.
– The device is not suitable for use while bathing, showering or in a hazardous explosive
environment.
– The pressure range to be set must be determined by a physician in accordance with
the age and weight of the patient.
– Do not use Thopaz+if the drainage therapy indicates a pressure greater than max.
pressure range of -10kPa.
– Do not use Thopaz+if the drainage therapy indicates a flow rate greater than max. flow
capacity of 5l/min.
– Do not use Thopaz+if the drainage therapy indicates no pressure should be applied to
the patient.
– Do not connect bilateral thoracic drains to one Thopaz+unit. In such cases, the use of
two Thopaz+units is recommended.
– To ensure Thopaz+can reduce the pressure, it is essential to wait 30seconds between
taking a drainage sample and unclamping the patient catheter (drain).
– Adapt pressure settings for pediatric patients.
– The use of Thopaz+for any other indication than intended is neither desired nor allowed.
– For use only by medically trained and qualified persons who have been adequately
trained in the use of Thopaz+.
– Wear gloves for all operations.
– The canister is replaced on the basis of a visual check or according to the instructions
on the Thopaz+display (warning signal).
– If a persistent air leak is shown, check the system is assembled correctly before taking
further corrective actions. Ensure the system is air tight by clamping the catheter and
observing the air leak decrease to zero.
–
The catheter/connector interface is a location where clotting may occur. We recommend
regular monitoring of this interface and appropriate removal procedure in case
of occurance.

EN
Warnings and safety instructions | 9
CAUTIONS
– No modification of this equipment is allowed.
– Before connecting Thopaz+to the power supply, please verify that the supply voltage
corresponds to that given on the device specification plate.
– Incorrect use of Thopaz+can cause pain and injury to the patient.
– Do not use sterile accessories when the sterile packaging is damaged.
– Non sterile and reusable accessories must be cleaned and disinfected according to
chapter 13 – General cleaning guidelines.
– For the initial startup do not switch Thopaz+on before first charging the battery.
– The Thopaz+2l canisters are not intended for portable use (not by hand and not using
the carrying strap).
– For safety reasons canister changes within the appropriate fluid level shall be recorded.
– Before diagnosing controll detected fluid value for plausability.
– For patients for whom a breakdown of the device can lead to a critical situation a
replacement device must always be available.
– Federal US law restricts this device to sale by or on the order of a health professional.
Safety related tip
– Never place Thopaz+with an attached 2l canister on the docking station without
attaching the optional adapter docking station 079.0038 for Thopaz+2l canister first.
– The acoustic alarm «Leak in system – 301» is deactivated for approximately 6minutes
after Thopaz+is switched on.
– Everytime a new patient is connected, it is recommended to carry out the functional
check.
–
Before the first application in accordance with the intended use, an inspection according
to IEC 62353 (see Appendix B) is recommended to acquire the reference values.

Safety instructions
– Thopaz+is a medical device that requires specific safety measures in regard to EMC.
It must be installed and put into operation in accordance with the attached EMC
information in chapter 19 – Technical documentation.
– Portable and mobile RF communications equipment can affect medical devices.
– In each of the following cases, Thopaz+must not be used and it must be repaired by
Customer Services:
– If the power cord or the plug are damaged
– If the device is not functioning according to routine check
– If the device is damaged
– If the device shows clear safety defects.
– Thopaz+has no user serviceable parts inside. For safety reasons, it is required that
Thopaz+is repaired throughout its service life strictly and exclusively by Medela
authorised service centres.
– Keep the power supply cord away from hot surfaces.
– The mains plug and the on/off switch must not come into contact with moisture. Never
pull the mains plug out of the fixed mains socket by pulling on the power supply cord.
– Thopaz+must stand upright during use.
– Separation from the mains is only assured through the disconnection of the mains
adapter and fixed socket connection.
– Never use the device at high room temperatures, while bathing or showering, if you
are very tired or in an environment where there is a risk of explosion.
– Never place Thopaz+in water or other liquids.
– When attaching a new canister, verify that the canister size displayed on screen is the
same size as the canister attached.
– When using single use, sterile products, please note that they are not intended to
be reprocessed. Reprocessing could cause loss of mechanical, chemical and /or
biological characteristics. Reuse could cause cross contamination.
– Contact your local Medela customer service representative for assistance with product
operations.
– The patient should be regularly monitored according to internal hospital guidelines.
These instructions for use must be kept for later reference.
10 | Warnings and safety instructions

EN
Power supply and battery operation | 11
2 Power supply and battery operation
Thopaz+can be operated from the mains power supply 077.0148, from the docking
station 079.0037 or with the integrated lithium-ion battery. Before using the docking
station, read first the docking station instructions 200.1554. The battery is charged
during mains operation. The battery duration is dependent on the run-time of Thopaz+.
This is influenced by the extent of parenchymal leakage and the set pressure. Thopaz+
does not run continuously but only switches on when the actual and nominal values differ.
During continuous operation, Medela guarantees a minimum run-time of 4hours in battery
operation after the device has been fully charged. In practical operation the real battery run
time results in >10hours.
If Thopaz+is not used very often, the battery must be charged approximately every 6months
to ensure optimum functioning.
Press simultaneously to acknowledge an acoustic alarm and
follow instructions on the display (see chapter 12 –
Troubleshooting and alarms).
Battery low
Approximately 30 minutes before the battery is fully empty an acoustic signal sounds and the
battery symbol [ ] starts to blink. The acoustic signal can be muted but the battery symbol
continues to blink until the battery is empty. The set pressure is maintained but the battery
should be recharged as soon as possible.
Charge battery
Plug the Thopaz+power supply into a wall outlet and open the
small protection cover to access the DC socket. Plug the coaxi-
al power supply into the DC socket. Moving bars on the battery
display will indicate charging is occurring [ ].
Backup battery
If an internal defect occurs (broken cable, battery defective) Thopaz+turns off and the
acoustic warning is sounded for at least 3 minutes (powered by a backup battery).
Under these conditions Thopaz+functions as a one way valve. Replace Thopaz+immediately.

12 | Power supply and battery operation
Battery empty
The battery symbol will blink with an acoustical sound for 10minutes prior to the battery fully
discharging, unless the pump is switched off earlier. The acoustic sound cannot be muted
during the 10minutes. If Thopaz+is not connected to a power source the pump will switch off
automatically after 10minutes. The negative pressure is not maintained after the pump turns off.
1. Battery empty
3. Battery is being charged
(moving bars)
2. Battery almost empty
4. Battery is fully charged and connected to the mains
*
* Symbol blinks
*

EN
Description | 13
3 Description
Introduction
Thopaz+is a high-quality digital chest drainage system. The compact system provides
regulated negative pressure close to the patient’s chest. It monitors the air leak and the fluid
collection. Thopaz+only applies vacuum required to maintain the negative pressure pre-
scribed and set by the managing physician. The digital colour display provides objective data
in real time as well as in historical graphs, which allows easy tracking of the therapy progress.
It combines easy handling and cleaning with safety features to ensure optimal operation.
Intended use/indications
Thopaz+is intended to be used for aspiration and removal of surgical fluids, tissue, gases,
bodily fluids or infectious materials. Thopaz+is indicated for all situations where chest drains
are applied – especially for thoracic drainage in the pleural and mediastinal cavity in situations
such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury,
pleural effusion, pleural empyema or other related conditions. Thopaz+is intended for use
on patients in appropriate care settings.
Contraindications
There are no known contraindications for the Thopaz+digital chest drainage system.
Important note
Compliance with proper surgical procedures and techniques is the responsibility of the
physician. Each physician must evaluate the appropriateness of the treatment based on his
own knowledge and experience.
Service life
The service life of the device is five years.
Intended patient population
Thopaz+is intended to be used on patients only exhibiting conditions as described in the
indications for use.
Intended user
Thopaz+should only be operated by properly instructed users. These persons must not be
hard of hearing or deaf and must have adequate visual faculty.

14 | Overview
4 Overview
Bed holder
Vacuum port
with seal
Standard rail holder
Specification plate
Carrying handle
Main elements of Thopaz+
Mains adapter port
Canister (ill. 0.3l)
USB port
Suction port
Light sensor
Display
Release button

EN
Overview | 15
Display
How to activate a button
Press the buttons briefly to activate the desired action.
Exception: for the function switch to «Standby», press the button for longer than 3 seconds.
Action bar
Action status of Thopaz+:
Optional buttons
Press simultaneously to change
pressure during operation
(see chapter 9 – Changing
pressure during operation)
Battery status
Air leak size
Set pressure
Total collected fluid amount
Therapy time
Patient numberThopaz+is out of axis
(fluid can currently not be measured)
Not enough fluid for
valid fluid measurement
USB connection
Thopaz+is running
Fluid history/
Selection button
Power on/off
Thopaz+is on Standby
Air leak history/
Selection button
Detected canister size
(check match with
attached canister)

16 | Overview
Tubings Normal/small/large/single/double connector
Material: PVC (medical grade) sterile, twofold packaging
Ø/ Length: 5mm / 1.5m
Thopaz tubing double
079.0022 Sample port
Measuring tube
Connection to pump
Overflow protection/bacteria filter
Tube clamp
Connection to canister
Thopaz tubing single
079.0021
Thopaz tubing single,
small connector
079.0023
Thopaz tubing double,
small connector
079.0024
Thopaz tubing single,
large connector
079.0025
Thopaz tubing double,
large connector
079.0026
Safety related tip
Medela recommends to use the biggest possible connector size compatible for the
catheter.
Patient connector single/double
Patient tube

EN
Overview | 17
Thopaz canister 0.8 l
079.0016
Thopaz canister 0.8 l with solidifier
079.0017
Canisters With/without solidifier 0.3l/0.8l/2l
Material: Polypropylene, sterile
Reading accuracy: +/- 2.5% (in upright position)
Solidifier: 0.3 l = 12g/ 0.8 l = 28g/ 2 l = 2x 30g
Thopaz canister 2 l
079.0018
Thopaz canister 2 l
with solidifier
079.0019
Thopaz canister 0.3 l
079.0011
Thopaz canister 0.3 l
with solidifier
079.0012
Safety chamber
Sealing cap
Label for canister detection
Graduation
Closed chamber with solidifier
Pressure relief valve
Overflow protection/bacteria filter
Secrection chamber

18 | Additional information
5 Additional information
Regulated pressure
The pressure is regularly checked and adjusted by Thopaz+. The set pressure corresponds
to the pressure of the entire Thopaz+system.
Safety pressure limit
The adjustable pressure range for Thopaz+is -0,1 to -10kPa (-100mbar, -75mmHg,
-100 cmH2O). If pressure values greater than -7kPa (-70mbar, -53 mmHg, -70 cmH2O)
are set, the following warning appears in the display: too high pressure levels can cause
pain and/or serious injuries to the patient. This warning must be acknowledged with «OK»
before the pressure can be increased further.
Definition of vacuum
By the application of medical aspiration devices, vacuum is normally given as the difference
(in absolute figures) between absolute pressure and atmospheric pressure or as negative val-
ues in kPa. In this document, the indication of -10kPa for example always refers to a pressure
range in kPa below atmospheric ambient pressure (according to EN ISO 10079:1999).
Tube flushing
Flushing of the tubing occurs every 5 minutes or when Thopaz+detects a siphon and
prevents clogging of the patient tubing.
Safety chamber in canister
For appropriate, safe operation Thopaz+must be in an upright position. If Thopaz+tips,
the special construction of the safety chamber in the upper region of the canister protects
the hydrophilic filter from premature clogging. The pressure is maintained. Important:
immediately set Thopaz+upright again. This function is disabled if the maximum filling
capacity of the canister is exceeded.
Fluid measurement
Thopaz+detects the fluid amount in the canister by a level sensor in the device. Therefore
Thopaz+needs to stay with a tolerance of 10° out of axis upright and the canister must
contain a minimal fluid amount of: 25ml in a 0.3 l canister, 50ml in a 0.8 l canister and 150ml
in a 2.0l canister. If these conditions are not fulfilled the fluid values appear in grey with a
crossed out fluid symbol [ ]. Additionally a Thopaz+out of axis symbol [ ] or a Thopaz+
not enough fluid symbol [ ] appears on the action bar. No additional fluid can be measured
in this status. The grey fluid values show the last measured fluid values.
The fluid measurements are displayed as accurate as follows: in a 0.3 l canister +/- 1ml, in a
0.8l canister +/- 5ml and in a 2 l canister +/- 10 ml.

EN
Additional information | 19
Overflow protection/bacteria filter
A hydrophilic overflow protection/bacteria filter in the canister as well as in the tube sets
(in the connector to Thopaz+) protects Thopaz+from the entry of fluids and protects the
environment from contamination.
Light sensor
Thopaz+is equipped with a light sensor. It adjusts the display brightness to the surrounding
light conditions. Thus, the patient does not get disturbed while sleeping by a bright shining
display.

20 | Installation
Check initial delivery
6 Installation
Check the delivery package of Thopaz+for completeness
and general condition.
Thopaz+
079.1000 with Instructions
for use 200.6841
079.1002 with Instructions
for use 200.6842
079.1003 with Instructions
for use 200.6843
Mains adapter international
077.014 8
Thopaz+CD
079.1007
Instructions for use
Cardiothoracic drainage
Thopaz+
™
EN
Instructions for use
DE
Gebrauchsanweisung
FR
Mode d’emploi
IT
Istruzioni per l’uso
NL
Gebruiksaanwijzing
SV
Bruksanvisning
ES
Instrucciones de uso
PT
Instruções de utilização
200.6841 (for 079.1000)
200.6842 (for 079.1002)
200.6843 (for 079.1003)
6.1