Medela Thopaz+ User manual

Thopaz
+™
Cardiothoracic Drainage
Precious life,
progressive care
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

xxxxxx | 3
www.medela.com
At the web address below you will find short how-to-use videos for Thopaz+.
Thopaz+University
Thopaz+University is designed to support you. Each video lasts no longer than 60 seconds and
includes text bullet points and voice commentary.
Thopaz+University can be found at www.medela.com via the “University” 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.

4 | Table of Contents
Table of Contents
Congratulations .................................................................................................................................. 6
1 Warnings and safety instructions ............................................................................................. 7
Safety instructions ...................................................................................................................... 10
2 Power supply and battery operation...................................................................................... 11
Backup battery............................................................................................................................11
Charge battery ...........................................................................................................................11
Battery low ................................................................................................................................. 12
Battery empty............................................................................................................................. 12
3 Description................................................................................................................................. 13
Introduction ................................................................................................................................ 13
Intended use/indications .......................................................................................................... 13
Contraindications....................................................................................................................... 13
Intended user.............................................................................................................................. 13
Intended patient population ..................................................................................................... 13
Important note............................................................................................................................ 13
4 Overview.................................................................................................................................... 14
Main elements of Thopaz+........................................................................................................ 14
Display........................................................................................................................................ 15
How to activate a button........................................................................................................... 15
Tubings........................................................................................................................................ 16
Canisters..................................................................................................................................... 18
5 Additional information ............................................................................................................. 19
Definition of vacuum.................................................................................................................. 19
Regulated pressure.................................................................................................................... 19
Safety pressure limit................................................................................................................... 19
Tube flushing............................................................................................................................... 19
Safety chamber in canister........................................................................................................ 19
Fluid measurement..................................................................................................................... 20
Limitations .................................................................................................................................. 20
Overflow protection/bacteria filter.......................................................................................... 21
Light sensor................................................................................................................................. 21
6 Installation ................................................................................................................................. 22
Check initial delivery.................................................................................................................. 22
Initial startup............................................................................................................................... 23
7 Preparation for use/operating instructions ........................................................................... 25
Checks before use ..................................................................................................................... 25
Connect tubing .......................................................................................................................... 25
Snap in canister.......................................................................................................................... 26
Using 2l canister ........................................................................................................................ 26
Switch Thopaz+on..................................................................................................................... 27
Carry out functional check........................................................................................................ 28
Check therapy progress............................................................................................................ 29

Table of Contents | 5
Main display............................................................................................................................... 29
Reset fluid display....................................................................................................................... 30
History......................................................................................................................................... 31
Catheter check........................................................................................................................... 33
Switching Thopaz+off ............................................................................................................... 34
Transfering data to PC with ThopEasy+................................................................................... 35
8 Replace canister ........................................................................................................................ 36
Canister with solidifier: activation of the solidification process .............................................. 37
9 Changing pressure during operation..................................................................................... 38
Physiological pressure ............................................................................................................... 38
10 Changing settings ..................................................................................................................... 39
Factory settings .......................................................................................................................... 39
Change settings......................................................................................................................... 40
Save a changed parameter as the new standard................................................................... 40
11 Taking a drainage sample ....................................................................................................... 41
12 Troubleshooting and alarms ................................................................................................... 42
Description ................................................................................................................................. 42
13 General cleaning guidelines.................................................................................................... 45
General notes ............................................................................................................................ 45
Disposables................................................................................................................................ 45
14 Warranty, maintenance and checks....................................................................................... 47
Warranty..................................................................................................................................... 47
Maintenance .............................................................................................................................. 47
Routine check ............................................................................................................................. 47
Instructions for FPT test .............................................................................................................. 47
Safety check ............................................................................................................................... 48
15 Disposal
..................................................................................................................................... 49
16 Accessories................................................................................................................................. 49
17 Technical specifications............................................................................................................ 50
18 Signs and symbols..................................................................................................................... 51
19 Technical documentation ....................................................................................................... 413
Appendix A ...................................................................................................................................... 418
Appendix B ......................................................................................................................................420
These instructions for use belong to firmware 1.01.
EN

6 | Congratulations
Congratulations
With Thopaz+ , you have acquired an innovative digital chest drainage system that sets new
standards 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.

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).
Additional equipment connected to medical electrical equipment must comply with the respective
IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configura-
tions 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 equipment
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.
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.
Subject to change.
WARNINGS
Indicates a potentially hazardous situation which, if not avoided, could result in death
or serious injury.
CAUTIONS
Indicates a potentially hazardous situation which, if not avoided, could result in minor
or moderate injury.
Safety related tip
Indicating useful information about the safe use of the device.
1 Warnings and safety instructions
EN

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).
– For pediatric patients adapt pressure settings according to hospital guidelines.
– 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 recom-
mend regular monitoring of this interface and appropriate removal procedure in case
of occurance.
– The Thopaz+system is not designed for retransfusion.

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.
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.
– Medela recommends to use the biggest possible connector size compatible for
the catheter.
– Use sample port of tubing to drain a sample. Therefore refer to chapter 11 – Taking a
drainage sample.
– Do not touch the patient and the docking contacts simultaneously.
– This product contains lithium-ion batteries which bear risk of fire, explosion and burns.
Do not disassemble, crash, heat above 100°C (212°F), incinerate or dispose of in fire.
– Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, walki-talkie can affect the Thopaz+
and should be kept at least a distance 30 cm away from the equipment.
– HF (high-frequency) surgical equipment, radio networks or the like can influence the
operation of the device and may not be operated in combination with the Thopaz+.
EN

10 | Warnings and safety instructions
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.
– 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.

Power supply and battery operation | 11
2 Power supply and battery operation
Thopaz+can be operated from the mains power supply 087.0059, 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.
Charge battery Plug the Thopaz+power supply into a wall outlet and open the
small protection cover to access the DC socket. Plug the coaxial
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 3minutes (powered by a backup battery). Under
these conditions Thopaz+functions as a one way valve. Replace Thopaz+immediately.
WARNINGS
This product contains lithium-ion batteries which bear risk of fire, explosion and burns.
Do not disassemble, crash, heat above 100°C (212°F), incinerate or dispose of in fire.
EN

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 automati-
cally 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
*
Press simultaneously to acknowledge an acoustic alarm and
follow instructions on the display (see chapter 12 – Trouble-
shooting and alarms).
Battery low
Approximately 30minutes 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.

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
prescribed and set by the managing physician. The digital colour display provides objec-
tive 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.
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.
Intended patient population
Thopaz+is intended to be used on patients only exhibiting conditions as described in the
indications for use.
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.
EN

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
WARNINGS
Do not touch the patient and the docking contacts simultaneously.
Docking contacts

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 number
Thopaz+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)
EN

16 | Overview
Tubings Normal/small/large/single/double connector
Material: PVC (medical grade) sterile, twofold packaging
Length: 1.5m
Thopaz tubing double
079.0022 Sample port
Measuring tube
Connection to pump
Tube clamp
Connection to canister
Patient connector single/double
Patient tube
Patient tube inner diameter
Connector outside diameter 2
Connector outside diameter 1
079.0025/26: Patient tube inner diameter: 5.5mm
Connector outside diameter 1: 9.5mm
Connector outside diameter 2: 16mm
079.0021/22: Patient tube inner diameter: 5.5mm
Connector outside diameter 1: 6.4mm
Connector outside diameter 2: 16mm
079.0023/24: Patient tube inner diameter: 5.5mm
Connector outside diameter 1: 4.0mm
Connector outside diameter 2: 11.0mm
Overflow/bacteria filter

Overview | 17
Thopaz tubing single,
large connector
079.0025
Thopaz tubing double,
large connector
079.0026
Thopaz tubing single
079.0021 Thopaz tubing double 079.0022
Thopaz tubing single,
small connector
079.0023
Thopaz tubing double,
small connector
079.0024
Safety related tip
Medela recommends to use the biggest possible connector size compatible for
the catheter.
EN

18 | Overview
Thopaz canister 0.8l, antifoaming
079.0016
Thopaz canister 0.8l with solidifier, antifoaming
079.0017
Canisters With/without solidifier 0.3l/0.8l/2l
Material: Polypropylene, sterile
Reading accuracy: +/- 2.5% (in upright position)
Solidifier: 0.3l = 12g/0.8l = 28g/2l = 2x30g
Simethicone capsule: Supports reliability of digital fluid
measurement (0.3l = 720mg/0.8l = 1440mg/2l = 1440mg
Simethicone)
Thopaz canister 2l,
antifoaming
079.0018
Thopaz canister 2l
with solidifier, antifoaming
079.0019
Thopaz canister 0.3l,
antifoaming
079.0 011
Thopaz canister 0.3l
with solidifier, antifoaming
079.0012
Safety chamber
Sealing cap
Label for canister detection
Graduation
Closed chamber with solidifier
Pressure relief valve
Overflow protection/bacteria filter
Secrection chamber
Safety related tip
Use sample port of tubing to drain a sample. Therefore refer to chapter 11 – Taking a
drainage sample.
Safety related tip
The simethicone capsule requires 60 min of submersion for full effect.
Simethicone capsule

Additional information | 19
5 Additional information
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 values
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).
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, -100cm-
HO). If pressure values greater than -7kPa (-70mbar, -53mmHg, -70 cmHO) 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.
Tube flushing
Flushing of the tubing occurs every 5minutes 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.
EN

20 | Additional information
Fluid measurement
Thopaz+calculates the fluid amount from the fluid level in the canister and in regard to the
attached canister size. The fluid level in the canister gets detected by capacitive coupling.
For a valid fluid measurement Thopaz+needs to stay within a tolerance of 10° vertical (upright)
and the canister must contain a minimal fluid amount of:
Thopaz canister without solidifier Thopaz canister with solidifier
30 ml in a 0.3l canister 40 ml in a 0.3l canister
50 ml in a 0.8 l canister 70ml in a 0.8 l canister
200ml in a 2.0 l 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.
This type of fluid measurement allows a measurement accuracy of +/-15ml in a 0.3l canister,
+/-40ml in a 0.8l canister and +/-100ml in a 2.0l canister (corresponding to +/-5% of the
canister volume).
Thopaz+displays the fluid values in a 0.3l canister in 1ml steps, in a 0.8l canister in 5ml steps
and in a 2.0l canister in 10ml steps. After a total drainage amount of 5000ml and more the
display will switch to liter (l). Thopaz+will display fluid values in 0.01l steps (equals 10ml steps)
thereupon.
Limitations
Thopaz+calculates the fluid measurement according the fluid level in the respective canister.
Movement of Thopaz+can cause fluids to temporary cover the canister walls. A potential fluid
film covering the canister wall can result in temporary higher fluid volume read out displayed on
the screen. Also foam formation in the canister can result in higher fluid volume read out
displayed on the screen. All Thopaz canisters (079.0011; 079.0012; 079.0016; 079.0017; 079.0018;
079.0019) are equipped with one or two simethicone capsules containing 720mg simethicone
each (see chapter 4 – Overview). Simethicone prevents foam formation and the coverage of fluid
films on the canister wall.
Safety related tip
For most accurate fluid measurement place or keep Thopaz+on the docking station
(079.0037).
Safety related tip
The simethicone capsule requires 60 min of submersion for full effect.