Medela Thopaz User manual

-10 kPa / 5 L/min
Thopaz™
Thoracic Drainage System
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 obsługi

AC
AC
kg
CLASS
70
106
kPa
30
75
20
95
AC
°C
-20
+50
°C
-5
+40
Technical specifications – Technische Daten – Données techniques –
Specifiche techniche – Technische specificaties – Tekniska specifikatio-
ner – Tekniske specifikationer – Especificaciones técnicas – Especificações
técnicas – Specyfikacja techniczna
Operation
Betrieb
Fonctionnement
Funzionamento
Gebruik
Drift
Drift
Funcionamiento
Funcionamento
Działanie
Transport/Storage
Transport/Lagerung
Transport/Stockage
Trasporto/Conservazione
Transport/Opslag
Transport/Förvaring
Transport/Opbevaring
Transporte/Alcanamiento
Transporte/Amazenamento
Transport/Magazynowanie
Mains adapter AC
Netzgerät AC Adapter
Adaptateur secteur
Adattatore di rete CA
AC adapter
Omkopplingsadapter AC
Netadapter AC
Adaptador de red CA
Adaptador de corrente AC
Przełączanie adaptera AC
Transport/Storage
Transport/Lagerung
Transport/Stockage
Trasporto/Conservazione
Transport/Opslag
Transport/Förvaring
Transport/Opbevaring
Transporte/Alcanamiento
Transporte/Amazenamento
Transport/Magazynowanie
Operation
Betrieb
Fonctionnement
Funzionamento
Gebruik
Drift
Drift
Funcionamiento
Funcionamento
Działanie
Operation
Betrieb
Fonctionnement
Funzionamento
Gebruik
Drift
Drift
Funcionamiento
Funcionamento
Działanie
Without canister
Ohne Behälter
Sans récipient
Senza contenitore
Zonder opvangpot
Utan behållare
Uden beholder
Sin recipiente
Sem recipiente
Bez pojemnika
Max. noise level
Max. Lautstärke
Niveau de bruit max.
Livello di rumore max.
Max. geluidsniveau
Max ljudnivå
Max. støjniveau
Nivel de ruido máx.
Nível de ruído máximo
Maks. poziom głośności
Alarm noise level
Alarm Lautstärke
Alarme de niveau de bruit
Livello di rumore allarme
Geluidniveau alarm
Larm ljudnivå
Alarmernes støjniveau
Nivel del ruido de la alarma
Nível de alarme de ruído
Poziom głośności alarmu
H x W x D
95 x 170 x 235 mm
3.74 x 6.69 x 9.25 inch
- 42.5 dB(A) 1 L -2,5 kPalow flow
5 L/min.
ISO 9001
ISO 13485
CE (93/42/EEC), IIa
Low vacuum
- 10 kPa
- 75 mmHg
- 100 mbar/cm H2O
20 W
12 VDC
1 kg
2,2 Ibs 78 dB(A)
Model: TR30RAM120
IEC: 60601-1
Input: 10-240V˜, 0.8-0.4A, 47-63 Hz
Output: 12V˜, 2.5A
Li-Ion

2
l
ll
EN
Indications
The system is used when negative pressure is required in combination with a thoracic drainage
catheter.
Contraindications
Thopaz cannot be used if:
• a pressure greater than -10 kPa or a flow of more than 5 L/min is required;
• applying active suction would put the patient at risk.
Medela does not recommend connecting bilateral thoracic drains to one Thopaz unit. In such
cases, the use of two Thopaz units is recommended.
Thopaz can be used for the following purposes:
• to remove air and/or fluids which gather in the intrapleural space as a result of illness,
injury or surgery;
• to regain or maintain negative pressure in the intrapleural space and to unfold the lungs.
Thopaz is intended for use on patients in all stages of the hospital. The unit should only be
operated by properly trained staff. These persons must not be hard of hearing or deaf and
must have adequate visual faculty.
Thopaz is portable and, thanks to a rechargeable battery, can be operated independently of
the mains supply. The built-in electronics allow you to make the necessary adjustments and
to track the effectiveness of the therapy during operation. Acoustic and optical signals are trig-
gered by variances during the course of treatment.
With Thopaz, you have acquired an innovative digital thoracic drainage system that sets new
standards in therapy and thoracic 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 very pleasant for the patient as well as
those in the vicinity.
Intended use
Congratulations

EN 3
lII
Safety instructions
• Thopaz must remain in an upright position during use.
• The patient should be regularly monitored according to internal hospital guidelines.
• 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.
• Thopaz is a medical device that requires special safety precautions and must be installed
and placed in operation in accordance with the attached EMC information. Portable and
mobile RF communication devices (mobile telephones) can affect Thopaz.
• A replacement device must always be available for patients for whom a breakdown of the
device can lead to a critical situation.
• In none of the following cases may Thopaz be placed in operation:
- if the power cord or plug is damaged
- if the device is not functioning properly
- if the device is damaged
- if the device has apparent safety defects.
• Keep the power cord away from hot surfaces.
• Keep the AC adapter connector away from moisture.
• Disconnection from the power supply is achieved by unplugging the mains adapter.
Warnings
• Before connecting Thopaz to the power supply, please verify that the supply voltage corre-
sponds to that given on the device specification plate.
• Data transfer via USB is not possible while the pump is connected to the patient.
• The device is not suitable for use while bathing, showering or in a hazardous explosive
environment.
• Do not use Thopaz in MRT (Magnetic Resonance Tomography).
• Do not dry Thopaz with microwaves.
Please read and observe these warnings and safety instructions before putting into
operation.
Thopaz is approved exclusively for use as described in these instructions. Medela can only
guarantee the safe functioning of the system when Thopaz is used in combination with the
original Medela accessories (canisters, tubing sets, carrying strap, mains adapter, docking sta-
tion).
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 60661-1-2 standard. Untested HF sources, radio networks or the like can impair the func-
tion of the device and should not be operated in the vicinity of Thopaz.
Warnings / Safety instructions
These instructions for use must be kept for later reference.

4EN
IV Initial startup
Check the condition of the delivery package and that it is complete.
Thopaz
Instructions for use
200.0685
200.0686
200.2004
Thopaz CD
079.0035
Mains adapter
077.0148
Thopaz™
079.0000
079.0002
079.0003
Do not switch Thopaz on before first charging the battery!
Initial startup
1. Select plug

EN 5
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.
If Thopaz was switched on before the battery was fully charged
(step 2), follow the instructions on the display.
a) Disconnect Thopaz from mains power – pull
on the plug housing.
Do not pull on the cable or the bend
protection!
b) Thopaz switches off automatically.
Battery is being
charged
Battery is fully
charged
after
max. 3 h
The battery must be fully charged before first usage.
2. Charging battery for the first time
Connect Thopaz to mains
3. Select language
a) Switch Thopaz on with [ ].
b) Select language (follow instructions on display), confirm with 'OK'.
c) Switch Thopaz off with [ ]. Thopaz is ready for use.

6EN
V
Bed holder
Vacuum port with seal
Selection button
Power on/off
Run/Standby indicatorBattery charging status
Information field
Display field
Navigation field
Standard rail holder
Carrying handle
Mains adapter port
Canister (ill. 0.3 L)
USB port
Specification plate
Suction port
Tubing guide
Display
Release button
Overview of Thopaz
Therapy number

EN 7
VI
Canister with/without solidifier 0.3 L and 0.8 L
Material: Polypropylene
Reading accuracy: +/- 2.5% (in upright position)
Solidifier: 0.3 L = 12 g / 0.8 L = 28 g Overflow protection/
Bacteria filter
Pressure relief valve
Sealing caps
Closed chamber with
solidifier
Tubing sets single / double
Material: PVC (medical grade)
sterile, twofold packaging
Ø / Length: 5 mm / 1.5 m
Tube clamp
Connection
to pump
Connection
to canister
Overflow protection/
Bacteria filter
Overflow protection / bacteria filter see 'Additional information'.
Patient tube
Patient connector single
Patient connector double
Measuring tube
Disposables
Safety chamber
Secretion chamber
Capacity 0.3 L
and 0.8 L
Graduation

8EN
VII
2
1
EN
3
click
Check required parts
Open external packaging.
Insert the smaller of the two connec-
tors horizontally in the direction of
the arrow.
Connect tubing set
Snap in canister
Unpack canister, position the openings
at the top and attach the bottom part of
the canister to the pump.
Push the canister into Thopaz
until you hear a click.
• Tubing set (single / double)
• Thopaz
Use only after instruction by qualified personnel.
'Pressure' generally implies 'negative pressure'.
Preparation for use
• Canister
(usable capacity in upright position
0.3 L / 0.8 L)
with solidifier
without solidifier

4
5
EN 9
1. Switch on Thopaz with [ ] – self-test starts
(check acoustic signal – [beep]).
Do not switch Thopaz on if the patient is already
connected.
If the self-test is not successful, see the troubleshooting
instructions on the display (Chapter XII).
Switching on
• 'yes' means that Thopaz will issue a
new therapy number (recommended
for a new patient).
• 'no' means that the therapy number
remains unchanged (recommended
for the continued treatment of the
same patient). The graphic presen-
tation is retained.
2. New patient? yes/no
The therapy number is important for data transfer
to the PC.
Therapy number
Carry out functional check
1. Seal off the conical connector of the patient tubing
with your thumb (through the packaging).
Flow decreases: Thopaz is ready for use
Flow does not decrease: Leak in the system;
check tubing connections,
replace canister and/or
tubing
2. • Switch on pressure by pressing 'on' – pressure is built up.
• Check flow value
3. Switch to Standby mode: Press 'Standby' (press for > 3 sec.)
4. Thopaz is in Standby mode and is ready for use with the
factory settings.
The tubing must not be kinked as otherwise the
measuring tube will be closed.

10 EN
VIII
1
3
2
EIN
Data mode
Graph mode
Lowest displayed flow value in data mode = 10 mL/min.
With 'Graph', the Graph mode is activated and the flow and
pressure progression are displayed on a time line. After 60 sec-
onds, the display switches back to the data mode.
With 'Data', you can switch to the Data mode at any time.
There are two different modes available:
Data mode and Graph mode
In the data mode, the set pressure value and the current flow
value (equivalent to parenchymal leakage) are digitally displayed.
Flow values between 0 and 1000 mL/min = 10 mL steps
Flow values over 1000 mL/min = 100 mL steps
Check therapy progress
Connect patient catheter in accordance with the
physician's directions.
Remove the inner packaging from the tubing.
Do not switch Thopaz on if the patient is already
connected.
1. Switch on Thopaz with [ ] – self-test starts.
Usage
2. New patient? yes/no.
3. • Switch on pressure by pressing 'on' – the pre-selected
pressure is built up and kept constant.
• Check flow value.
The acoustic alarm function "Leak in system - 301" is
deactivated for approximately 5 minutes after switching
on.
Usage

EN 11
If Thopaz does not show the respiratory movements,
request the patient to breathe slowly and deeply.
catheter open
Zoom mode and catheter check
1. The zoom function is activated with the selection button [ ].
The flow scale is reduced to 100 mL/min.
Return to the Graph mode with the selection button [ ].
2. In zoom mode, the pressure differencebetween inspiration and
expiration is displayed at a flow of 0 mL/min. This pressure dif-
ference is an indication for the respiration cycle of the patient
and confirms that the catheter is not clogged.
• The current flow and pressure values are indicated in the
information field.
• The left scale shows the pressure in the desired unit
(max. -10 kPa). The pressure is presented as a filled area.
• The right scale shows the flow in the desired unit
(max. 1000 mL). The flow values are presented as a line.
Graphic presentation
The Graph mode shows the flow and pressure progression as
a function of time. The graph is updated every ten minutes. The
displayed graph is first meaningful after 4 hours.
Flow scale
Pressure scale
Flow
Pressure
Current pressure and flow values
Current time
Indicator only visible in zoom
mode at a flow of 0 mL/min
catheter clogged?

12 EN
4
1. Close patient tubing with the tube clamp.
2. Switch off pressure by pressing 'Standby' (press for > 3 sec.)
– Thopaz switches to standby mode.
3. Release, remove and seal the canister.
4. Dispose of canister and patient tubing in accordance with
internal hospital guidelines.
5. Switch off Thopaz [ ].
Option: Transfer data to PC – see Chapter XI.
Switching off

EN 13
IX
9
5
4
press&
shake
technology
TM
The canister is replaced on the basis of a visual check or according to the instructions on
the display (warning signal).
Replace canister
1. Prepare sterile canister (with/without solidifier).
2. Close patient tubing with the tube clamp.
3. 'Standby' (press for > 3 sec.)
Thopaz switches to the Standby mode.
4. Release and remove canister.
5. Unpack new canister, position into Thopaz
and snap in (Chapter VII).
6. Press 'on'. Pressure is built up.
7. Open the tube clamp.
8. Check flow value.
9. Seal the used canister with the sealing caps.
Only for canisters with solidifier:
10. Dispose of the used canister in accordance with internal hospital
guidelines.
a) Press – to open the
solidifier chamber. b) Shake – to activate the solidification process.

14 EN
X
+
+
The settings may only be changed by the physician or on medical orders.
Change settings
Change pressure
a) Press [ ] and [ ] simultaneously. The pressure is indicated on the
display.
b) With the selection buttons set the desired pressure and confirm with 'OK'.
c) To activate the gravity mode press the [ ] button and confirm with 'OK'.
For patients who are to be treated by gravity drainage (= water seal), the
gravity mode can be activated. This mode corresponds to a pressure of
-0.8 kPa / -8 cmH2O / -8 mbar / -6 mmHg.
Standby mode
Making settings
a) With the selection buttons, select the desired parameter and confirm with
'OK'.
b) With the selection buttons, select the desired setting and confirm with 'OK'.
c) With the 'back' button, the settings mode is ended and the standby
mode is activated.
Press simultaneously
Press simultaneously
Operating mode

EN 15
XI
Selection
max. -10 kPa / -100 cmH2O
kPa / cmH2O / mbar / mmHg
mL/min / L/min
off / on
no / yes
cmH2O is not a SI unit according to
EU Directive 80/181/EEC.
Selection
Languages according to list
Display
Display
Display
Set as standard
Thopaz is delivered with the following factory settings.
To save the selected settings, confirm pa‑
rameter 'Set as standard' with 'yes'.
Press 'back' to activate the standby mode.
With the software ThopEasy all stored data can be transferred to a PC as documentation and
for completion of the patient records. The data can be expanded with patient information,
saved and printed.
The operating instructions for data transfer and the software ThopEasy can be found on the
Thopaz CD included in the scope of delivery.
Data transfer to PC
These settings can be changed and saved as
the new standard and are active whenever
Thopaz is switched on.

16 EN
XII
✘
✔beepbeep
beep
Internal error
The problem cannot
be rectified by the
user. The error
number
is displayed.
Alarm
Pressure is
interrupted
Warning
Pressure is
maintained
Acknowledge
acoustic
alarm
Press simul-
taneously
Example:
Problem description
on display
Troubleshooting
instructions are
displayed
Error number
Thopaz distinguishes between warnings, alarms and errors.
If Thopaz detects any of these situations, an acoustic warning signal sounds and a description
of the problem appears on the display. By pressing the two selection buttons simultaneously,
the acoustic alarm is suppressed for 60 seconds and the troubleshooting instructions appear
on the display.
Alarms

EN 17
Visible on display
Error
number
Problem
description
Troubleshooting
instructions
Remarks /
Potential source of error
Pres-
sure
Warning
401 Battery low Charge battery – con-
nect Thopaz to mains
Remaining time of battery
approx. 30 min.
306 Canister full Replace canister If the canister is not full, see
Chapter XIII
405 Standby mode Switch Thopaz on
or off
In standby mode after 5
minutes
404 Leakage • Check patient status
• Check system for
leaks
• Continue with 'OK'
• Irregularity in the course of
therapy
• Indication of leakage
• See Chapter XIII
402 USB connection
not permitted
Unplug USB
cable
USB connection not permitted
during operation or in the
vicinity of the patient
406 Temperature too
high
Prepare backup
device
Cool Thopaz (for example with
a fan, hair dryer, etc.).
Do not expose Thopaz to direct
sunlight.
Alarm
305 Battery empty Charge battery – con-
nect Thopaz to mains
302 System clogged • Check that tubing is
clear/not twisted
• Replace canister
• Tubing is kinked or clogged
• Filter in canister clogged
301 Leak in system Check system for
leaks
• Disconnection
• Missing seal between
Thopaz and canister
311 Selftest failed Snap the canister out
and in again
Do not switch Thopaz on if
the patient is already con-
nected.
313 Filter clogged • Replace canister
• Continue with 'on'
Filter in canister clogged
315 Thopaz overheated Replace Thopaz
Internal
error
Internal error
XXX
1 Switch Thopaz off
and on again
2 Inform Medela
Customer Service
If error message repeated,
inform Medela Customer
Service
✔
✘
✘
✘
✔
✔
✔
✘
✘
✘
✘
✔

18 EN
XlII
Safety chamber in canister
For appropriate, safe operation Thopaz must be in an upright position. If Thopaz tips, the spe-
cial construction of the safety chamber in the upper region of the canister protects the hydro-
phobic filter from premature clogging. The pressure is maintained.
Additional information
Pressure value cmH2O mbar mmHg
-7 kPa -70 -70 -53
-10 kPa -100 -100 -75
Regulation
The pressure is regularly checked and adjusted by Thopaz. The set pressure corresponds to
the pressure of the entire system including the patient.
Overflow protection / bacteria filter
A hydrophobic overflow protection / bacteria filter in the canister as well as in the tube sets (in
the connector to the pump) protects Thopaz from the entry of fluids and protects the environ-
ment from contamination.
Canister full
If secretions line the walls of the canister, the warning 'canister full' may be activated prematurely.
The warning 'canister full' is triggered only once. After cancelling the warning with the selection
buttons, it is deactivated and a symbol [ ] flashes in the run mode.
After deactivation of the warning, the user is responsible for checking the canister filling level.
If the hydrophobic overflow/bacteria filter gets clogged by fluids, the alarm 'System clogged'
is triggered.
The warning is reactivated under the following conditions:
- if Thopaz is switched off and then on again – for example, on replacing the canister.
- if the level sensor is not activated for at least 10 minutes.
Leakage
A significant and sustained increase in the flow rate indicates that there is a leakage in
the system or on irregularity in the course of therapy. This function can be switched on as
required - see Chapter X.
This function is disabled if the maximum filling capacity of the canister is exceeded.
Important: immediately set Thopaz upright again.
Tube flushing
Flushing of the tubing occurs every 5 minutes or when Thopaz detects a siphon and prevents
clogging of the patient tubing.
If pressure values greater than -7 kPa 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.
Safety pressure limit
The adjustable pressure range for Thopaz
is 0 to -10 kPa.

EN 19
XlV
XV
✔ ✘✔
Optional accessories
Cleaning
079.0031
Carrying strap
079.0037
Docking station
(is delivered without mains
adapter)
079.0034
USB - standard cable
(not included in scope of delivery)
Thopaz with accessories should be cleaned / disinfected after every use.
General notes
• The internal hospital guidelines take precedence.
• Disconnect Thopaz from the mains before cleaning / disinfection.
• Classification according to RKI (Robert Koch Institut) guidelines: non-critical.
• Wear suitable gloves for cleaning / disinfection.
• Dispose of fluids such as blood and secretions and the parts contaminated with them in
accordance with internal hospital guidelines.
• Detailed information according to Medela cleaning instructions Art. No.200.2391.
Thopaz /
Docking station
Disposables
(canister, tubing set)
Caution: This is a single use product not intended to be
reprocessed. Reprocessing could cause loss of mechani-
cal, chemical and / or biological characteristics. Reuse
could cause cross contamination.
Wipe off with a
damp cloth. Wipe off with a disinfecting agent,
e.g., Mikrozid AF
Liquid (supplier
Schülke + Mayr).
• Not sterilisable.
• Rinsing in a washing
machine is not permitted.
• Immersion disinfection,
thermal disinfection and
ultrasound cleaning are not
permitted.
Cleaning Disinfection Sterilisation
Rinse cycle
in washing
machines
Thopaz can be disinfected with the disinfecting agent group 'alcohol'.
Do not use other cleaning agents (e.g. Terralin) as they could damage the plastic housing.
Accessories
(e.g. docking
station, carrying
strap)