Medela Thopaz User manual

EN Instructions for use
DE Gebrauchsanweisung
FR Mode d’emploi
IT Istruzioni per l’uso
NL Gebruiksaanwijzing
SV Bruksanvisning
DA Brugsanvisning
ES Instrucciones de uso
PT Instruções de utilização
PL Instrukcja obslugi
Thopaz ™
DIGITAL CHEST DRAINAGE SYSTEM

www.medela.com
At the web address below you will find short how-to-use videos for Thopaz.
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.
Thopaz University

4 | Table of Contents
Congratulations ............................................................................................................................6
1 Warnings and safety instructions.........................................................................................7
Safety instructions....................................................................................................................9
2 Power supply and battery operation..................................................................................10
Backup battery.......................................................................................................................10
3 Charge battery ..................................................................................................................... 11
Battery low ............................................................................................................................. 11
Battery empty......................................................................................................................... 11
4 Description ...........................................................................................................................12
Introduction ............................................................................................................................12
Intended use/indications .......................................................................................................12
Contraindications ...................................................................................................................12
Intended user .........................................................................................................................12
Intended patient population....................................................................................................12
Important note........................................................................................................................12
5 Overview ...............................................................................................................................13
Definition of vacuum...............................................................................................................13
Main elements of Thopaz.......................................................................................................13
Operating elements................................................................................................................14
Activating buttons................................................................................................................... 14
Tubings...................................................................................................................................15
Canisters ................................................................................................................................17
6 Additional information .........................................................................................................18
Regulated pressure ................................................................................................................18
Safety pressure limit...............................................................................................................18
Tube flushing ..........................................................................................................................18
Safety chamber in canister.....................................................................................................18
Overflow protection /bacteria filter..........................................................................................18
Leakage warning (does not correspond to «Leak in system» alarm)......................................18
7 Installation ............................................................................................................................19
Check initial delivery...............................................................................................................19
Initial startup...........................................................................................................................20
8 Preparation for use/operating instructions ......................................................................22
Checks before use .................................................................................................................22
Connect tubing.......................................................................................................................22
Snap in canister......................................................................................................................23
Using 2 L canister ...................................................................................................................23
Switch Thopaz on ..................................................................................................................24
Table of Contents

EN
Table of Contents | 5
Carry out functional check .....................................................................................................25
Check therapy progress.........................................................................................................26
Rounding Function .................................................................................................................26
Graph mode...........................................................................................................................27
Zoom mode............................................................................................................................28
Catheter check.......................................................................................................................28
Switching Thopaz off..............................................................................................................29
Transfering data to PC with ThopEasy+.................................................................................29
9 Replace canister ..................................................................................................................30
Canister with solidifier: activation of the solidification process...............................................31
10 Changing pressure...............................................................................................................32
Change pressure....................................................................................................................32
Gravity mode..........................................................................................................................32
11 Changing settings................................................................................................................33
Change settings .....................................................................................................................33
Factory settings......................................................................................................................34
Setting a changed parameter as standard.............................................................................34
12 Taking a drainage sample ...................................................................................................35
13 Troubleshooting and alarms ...............................................................................................36
Pump not running...................................................................................................................36
Description .............................................................................................................................36
Canister full.............................................................................................................................38
14 Warranty, maintenance and checks...................................................................................39
Warranty.................................................................................................................................39
Maintenance...........................................................................................................................39
Routine Check........................................................................................................................39
Instructions for FPT test .........................................................................................................40
Safety Check..........................................................................................................................41
15 General cleaning guidelines................................................................................................42
General notes.........................................................................................................................42
Disposables............................................................................................................................42
16 Accessories ..........................................................................................................................44
17 Signs and symbols...............................................................................................................45
18 Technical specifications......................................................................................................47
19 Disposal ................................................................................................................................48
20 Technical documentation ..................................................................................................473
Appendix A................................................................................................................................478
Appendix B.............................................................................................................................. 480

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 and extreme quietness of operation are 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 Medela accessories (canisters, tubings, carrying strap, mains adapter,
docking station – see chapter 16).
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 representative or the 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.
1 Warnings and safety instructions
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.

8 | Warnings and safety instructions
WARNINGS
– Consult this manual prior to use.
– Data transfer via USB is not allowed during therapy.
– Before cleaning the device, pull the plug out of the fixed mains socket.
– 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.
– The secretions gathered must be monitored more regularly or frequently in accordance
with the age and weight of the patient.
– To ensure Thopaz can reduce the pressure, it is essential to wait 30seconds between
taking the sample from the sample port and unclamping the patient catheter (drain).
– Do not use Thopaz if the drainage therapy indicates a pressure greater than Thopaz
max. pressure range of -10kPa.
– Do not use Thopaz if the drainage therapy indicates a flow rate greater than Thopaz
max. flow capacity of 5l/min.
– Do not use Thopaz if the drainage therapy indicates no pressure should be applied to
the patient.
– 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.
– Do not connect bilateral thoracic drains to one Thopaz unit. In such cases, the use of
two Thopaz units is recommended.
– The use of Thopaz for any other indication than intended is neither desired nor allowed.
– The Thopaz system is not designed for retransfusion.
– This product contains lithium-ion batteries which bear risk of fire, explosion and burns.
Do not dissassemble, crash, heat above 100°C (212°F), incinerate or dispose of in fire.
– For pediatric patients adapt pressure settings according to hospital guidelines.
– Do not touch the patient and the docking contacts simultaneously.

EN
Warnings and safety instructions | 9
CAUTIONS
– No modification of all articles related to the Thopaz system 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 can cause pain and injury to the patient.
– Do not use sterile accessories when the sterile packaging is damaged.
– 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
– A visual inspection of the housing and power cord must be carried out before each
use.
– Before you plug in the device, please check that your local power supply is the same
as the voltage given on the specification plate.
Safety instructions
– Thopaz is a medical device that requires special safety measures in regard to EMC.
It must be installed and put into operation in accordance with the attached EMC
information in chapter 22.
– 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 manuacturer.
– if the device is damaged.
– if the device shows safety defects.
– 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 using single use, sterile products, please note that they are not intended to
be reprocessed. Reprocessing could cause loss of mechanical, chemical and /or

10 | Power supply and battery operation
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 on mains operation
or on docking station. 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 negative pressure differ.
During continuous operation, Medela guarantees a minimum run-time of 4 hours in battery
operation after the device has been fully charged. In practical operation the real battery run
time results in >10 hours.
If Thopaz is not used very often, the battery must be charged approximately every 6 months
to ensure optimum functioning.
Safety related tip
Backup battery
If an internal defect occurs (broken cable, battery defective), an acoustic warning
signal is sounded for at least 3 minutes. Power is supplied by the backup battery.
Replace Thopaz immediately.
biological characteristics. Reuse could cause cross contamination.
– Contact your local Medela customer service representative for assistance with product
operations.
– Wear gloves for all operations.
– The patient should be regularly monitored according to internal hospital guidelines.
– A replacement device must always be available for patients for whom a breakdown of
the device can lead to a critical situation.
These instructions for use must be kept for later reference.
WARNINGS
This product contains lithium-ion batteries which bear risk of fire, explosion and burns.
Do not dissassemble, crash, heat above 100 °C (212 °F), incinerate or dispose of in fire.

EN
Charge battery | 11
3 Charge battery
Press simultaneously,then follow the instructions on
the display
to acknowledge an acoustic alarm (see chapter 13)
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.
Battery empty
The battery symbol will blink with an acoustic sound for 10minutes prior to the battery fully
discharging, unless the pump is switched off earlier. The acoustic sound cannot be muted
during the 10 minutes. If Thopaz is not connected to a power source the system will switch off
automatically after 10minutes. The negative pressure is not maintained after the system turns off.
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 [ ].
1. Battery empty
(sign is blinking) 3. Battery is being charged
(moving bars)
2. Battery almost empty 4. Battery is fully charged

12 | Description
4 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 only
applies the suction required to maintain the negative pressure prescribed and set by the
managing physician. The digital display provides objective data in real time as well as a
24-hour historical graph of the air leak, which allows easy tracking of the therapy progress.
The system 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 trained 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.
Intended use

EN
Overview | 13
5 Overview
Bed holder
Vacuum port
with seal
Standard rail holder
Specification plate
Docking contacts
Carrying handle
Main elements of Thopaz
Mains adapter port
Canister (ill. 0.3l)
USB port
Suction port
Tubing guide
Display
Release button
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 Kilopascal (kPa). In this document, the indication of -10 kPa for example always
refers to a pressure range in kPa below atmospheric ambient pressure (according to
EN ISO 10079:1999).

14 | Overview
Operating elements
Power on/off
Battery charging status
Press simultaneously,
then follow the instruc-
tions on the display
Press simultaneously
Switch to Standby mode
by pressing «Standby» for
longer than 3seconds.
Therapy number
Run/Standby indicator
to acknowledge
an acoustic alarm
(see chapter 13)
to change pressure and settings
(see chapter 10, 11)
Activating buttons
Press the buttons briefly to activate.
Exception: The «Standby» button must be pressed for longer than 3seconds to prevent
an unintended interruption of the therapy.

EN
Overview | 15
Tubings Normal/small/large/single/double connector
Material: PVC (medical grade) sterile, twofold packaging
Length: 1.5 m
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: 5.5 mm
Connector outside diameter 1: 9.5 mm
Connector outside diameter 2: 16 mm
079.0021/22: Patient tube inner diameter: 5.5 mm
Connector outside diameter 1: 6.4 mm
Connector outside diameter 2: 16 mm
079.0023/24: Patient tube inner diameter: 5.5 mm
Connector outside diameter 1: 4.0 mm
Connector outside diameter 2: 11.0 mm
Overflow protection/bacteria filter
accessories

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.
16 | Overview

EN
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: 0.3 l = 12g / 0.8 l = 28g/ 2 l = 2 x 30g
Simethicone capsule: prevents foaming
(0.3 l = 720mg/0.8l =1440mg / 2 l = 1440 mg Simethicone)
Thopaz canister 2l,
antifoaming
079.0018
Thopaz canister 2l
with solidifier, antifoaming
079.0019
Thopaz canister 0.3l,
antifoaming
079.0011
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
Simethicone capsule
Safety related tip
Use sample port of tubing to drain a sample. Therefore refer to chapter 12 – Taking a
drainage sample.
The simethicone capsule requires 60 min of submersion for full effect.
Overview | 17

18 | Additional information
6 Additional information
Regulated pressure
The pressure is regularly checked and adjusted by Thopaz. The set pressure corresponds to
the pressure of the entire system including the patient.
Safety pressure limit
The adjustable pressure range for Thopaz is -0,1 to -10kPa (-100 mbar, -75 mmHg). If pressure
value is greater than -7 kPa (-70mbar, -53 mmHg) are set, the following warning appears in
the display: too high pressure can cause pain and 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 approximately 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 feature is disabled if the maximum filling
capacity of the canister is exceeded.
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.
Leakage warning (does not correspond to «Leak in system» alarm)
A significant and sustained increase in the flow rate indicates that there is a leakage in
the system or an irregularity in the course of therapy. This function can be switched on
as required - see chapter 11.

EN
Installation | 19
Check initial delivery
7 Installation
Check the delivery package of Thopaz for completeness and
general condition.
Thopaz™
079.0000 with Instructions for
use 200.0685
079.0002 with Instructions for
use 200.0686
079.0003 with Instructions for
use 200.2004 / 101034234
Thopaz wall mains adapter coaxial
DC plug
077.0148
Thopaz CD
079.0035
Instructions for use
200.0685 (for 079.0000)
200.0686 (for 079.0002)
200.2004 / 101034234
(for 079.0003)
EN
Instructions for use
DE
Gebrauchsanweisung
FR
Mode d’emploi
IT
Istruzioni per l’uso
NL
Gebruiksaanwijzing
SV
Bruksanvisning
DA
Brugsanvisning
ES
Instrucciones de uso
PT
Instruções de utilização
PL
Instrukcja obslugi
Thopaz
™
DIGITAL CHEST DRAINAGE SYSTEM
7.1
accessories

20 | Installation
Checks before use
– Check Thopaz system before use for damage of the power cord or plug, obvious
device damage or safety defects and proper functioning of the device.
– Check for completeness and general condition of Thopaz delivery package.
7.2a
3. 3.1 Charge for approximately
3hours or until the [ ]
symbol appears in the
display.
3.2 Press [ ] to switch
Thopaz on. A selftest
starts.
Important: Do not yet connect the patient to the system.
2. 2.1 Connect Thopaz to mains
by mains adapter
077.0148 or by docking
station 079.0 0 37.
Initial startup
procedure
1. 1.1 Select plug.
1.2 Attach plug to the mains
adapter 077.014 8.
7.2b
Initial startup
7.2
WARNINGS
For use only after instruction by medically trained and qualified persons who have been
adequately trained in the use of Thopaz.
CAUTIONS
Before the first application in accordance with the intended use, an inspection
according to IEC 62353 (see Appendix B) is recommended.