Medela Thopaz User manual

Thoraxdrainage-System
©Medela AG/200.0685/04.08/B
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Medela AG, Medical Technology
Lättichstrasse 4b
6341 Baar/Switzerland
Phone [phone]
Fax [phone]
[email protected]
www.medela.com
France
Medela France Sarl
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91154 Etampes cedex
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Germany
Medela Medizintechnik
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85378 Eching
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Italy
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Medela Benelux BV
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Productos Medicinales Medela S.L.
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Sweden
Medela Medical AB
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Medela AG, Medizintechnik
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Medela UK Ltd.
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4Instruction for use
4Gebrauchsanweisung
Thopaz™
Precious life Progressive care
nur für
internen Gebrauch
-10 kPa /5l/min

Please see accompanying papers •Begleitpapierebeachten
IP33
Signs and Symbols •Zeichen und Symbole
☛
5l/min.
lowflow
1kg/2,2 lbs
kg
Operation
Betrieb
70
106
kPa
Te chnical specifications •Te chnische Daten
Operation
Betrieb
°C
-5
+40
Transport/Storage
Transport/Lagerung
°C
-20
+50
Switching adapter AC
Netzgerät AC Adapter Model: TR30RAM120
IEC: 60601-1
Input: 100-240V~, 0.8-0.4A, 47-63Hz
Output: 12V ,2.5A
Max. noise level
Max. Lautstärke
-42,5 dB(A) 1l -2,5 kPa
-10kPa
-75mmHg
-100 mbar/cm H 2O
lowvacuum
Alarm noise level
Alarm Lautstärke
78 dB(A)
ISO 9001
ISO 13485
CE (93/42/EEC), IIa
CLASS
IP33
95 x170 x235 mm
3.74 x6.69 x9.25 inch
75 Operation
Betrieb
30
95 Transport/Storage
Transport/Lagerung
20
without jar
ohne Behälter
Check •kontrollieren
USB -Stecker •USB -Stick
Important information •wichtiger Hinweis
Protection against ingress of solids larger than 2.5 mm and spraying water •geschützt gegen Eindringen
von festen Fremdkörpern>2.5 mm /Sprühwasser
Protection Class II •Schutzklasse ll
Disposable article –donot reuse •Einweg-Artikel –nicht wiederverwendbar
Type CF •TypCF
Must not be disposed of together with household refuse •Darf nicht zusammen mit Hausmüll entsorgt
werden
Battery charging (Thopaz connected to mains power supply) •Akku laden (Thopaz am Netz)
Battery charged (Thopaz connected to mains power supply) •Akku geladen (Thopaz am Netz)
20 W
12 VDC

11
Caution: Federal law restricts this device to sale by or on the
order of ahealth professional.
Instructions for use 2
EN
DE Gebrauchsanweisung 22

EN
Congratulations
l
With Thopaz,you have acquired an innovative digital drainage system that has set new stan-
dards for thoracic drainage management.
Thopazis an electronic measuring and monitoring system with optical and acoustical safetyfea-
tures. The device is adrysystem, which means no fluids arenecessaryfor operation. It has the
capabilityto displaythe course of therapydigitallyand graphically.Upon completion of therapy,
it can be transferred to aPC.
The handysizeand quietness while in operation areother advantages Thopazoffer to the
patients.
Thopazmaintains negative pressureinthe pleural space and collects fluids and/or air.
Thopazis portable and can be operated independent of the mains power source because of
the internal rechargeable battery.The built-in electronics allow you to make the necessary
adjustments and track the effectiveness of therapyduring operation. Acoustical and optical
signals aretriggered byvariances during the course of treatment (XII).
Thopazis intended for use on patients in all stages of the hospital. The unit should onlybe
operated byproperlytrained staff.
Indications
The system is used when negative pressureisrequired in combination with an athoracic drai-
nage catheter.
Contraindications
•Ifanair flow of greater than 5l/min is necessary.Thopazcannot be used.
•Under no circumstances do Medela advise connecting bilateral thoracic drains to asingle
pump. In such cases, the use of two Thopazunits is recommended.
•During in-home use, Medela does not recommend the use of Thopazbypatients who are
visuallyand/or audiblyimpaired.
Use in accordance with the instructions
ll
2

EN 3
Warnings /Safety instructions
lII
Thopazis approved exclusivelyfor the use as described in these instructions. If Thopazis not
used in combination with the original Medela accessories (disposable canisters; tubing set; car-
rying strap; mains adapter; and docking station), Medela cannot guarantee the safe function of
the system.
Thopazis EMC-tested in conformitywith the requirements of IEC 60601-1-2:2001. It shall be
used in the vicinityof other EMC-tested devices that fulfill the requirements as outlined in the
IEC 60661-1-2 standard. Untested HF sources, radio networks or the like can influence the
operation of the device and should not be operated in the vicinityof Thopaz.
Please read and observe these warnings and safety instructions before operation.
Warnings
•Beforeyou plug the device into the power supply,please verifythe voltage at the local
power supplyis the same as given on the specification plate of Thopaz.
•Data transfer via USB is not possible while the pump is connected to the patient.
•The device is not for use while bathing, showering nor suitable for ahazardous explosive
environment.
•Donot use Thopazin MRT(Magnetic Resonance Tomography).
•Donot dryThopazwith microwaves.
Safety instructions
•Thopazmust remain in an upright position during use.
•The patient should be regularlymonitored according to internal hospital guidelines.
•Thopazis amedical device that requires special safetyprecautions 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.
•Areplacement device must alwaysbeavailable for patients for whom abreakdown of the
device can lead to acritical situation.
•Innone of the following cases mayThopazbe placed in operation:
−Ifthe power cordorplug is damaged
−Ifthe device is not functioning properly
−Ifthe device is damaged
−Ifthe device has apparent safetydefects
•Keep the power cordawayfrom hot surfaces.
•Keep the AC adapter connector awayfrom moisture.
•Separation from the power supplyoccurs byunplugging the mains adapter.
These instructions for use must be kept for later reference.

4EN
Initial setup
IV
Thopaz
Instruction for Use
200.0685
Thopaz-CD
079.0035
Mains adapter
077.0106
Thopaz™
079.0000
Check the delivery package for completeness and general condition.
Initial setup
1. Select your plug
Do not switch on Thopaz beforefirst battery charge!

EN 5
after
max.
3h
Battery is being
charged
Battery is fully
charged
2. Charge battery beforefirst use
Connect Thopazto mains power,
batteryis being charged
The batterymust be fully charged before first use.
3. Select language
a) Switch Thopazon with [],self test starts.
b) Select language (byfollowing instructions on display), confirm with “Ok”.
c) Switch Thopazoffwith [].Thopazis now readyfor use.
If Thopaz was switched on before batterywas fully charged (step 2),
follow the instruction on the display.
4. Cleaning
Classification according to RKI* guideline: non-critical.
Disinfection
Thopazcan be disinfected with the disinfecting agent group “alcohol”.
Do not use other cleaning agents (e.g. Terralin) as theycan damage the plastic
housing.
Immersion disinfection, thermal disinfection and ultrasound cleaning arenot per-
mitted.
Sterilization
Thopazand Thopazaccessoryparts arenot sterilizable.
*Robert Koch Institute, Berlin, Germany
a) Disconnect Thopaz from mains power -
pull on the plug housing.
Do not pull on the cable or the anti-bend
protection!
b) Thopazswitches offautomatically

EN
Operating elements
V
Tubing guide
Mains adapter port
Bed holder
Canister (ill. 0.3 l)
Carrying handle
Suction port
Release button
USB port
Specification plate
Standardrail holder
On /Off
Selection button
Instructions /alarms
Batterycharging status
Displayfield
Pressureindicator
Navigation field
Display
Information field
6
Therapynumber
Vacuum port with seal

EN 7
Disposables
VI
Safetychamber
Suction chamber
Capacity0.3 L
and 0.8 L
overflow protection /
bacteria filter
Sealing cap
Canister 0.3 Lund 0.8 L
Material: Polypropylene
Accuracyof graduation: +/- 2.5% (in the upright position)
Double lumen tubing with single /double connection
Material: PVC (medical grade)
Length: 1.5 m
Ø: 5mm
Clamp
Measuring tubing
Connection
to pump
Connection
to canister
Patient single connection
Pressurerelief valve
Patient double connection
Patient tubing
Graduation

8EN
Check necessary parts
•Thopaz
•Tubing (single /double)
•Canister
(usable capacityin upright
position 0.3 l/0.8 l)
Preparation for use
VII
2Open external packaging.
Byinsertion of smallest connection into
pump, lock tubing in the direction of the
arrow.
Connect tubing
3
Unpack canister and position the ope-
nings up, insert the lower portion of
canister into place.
Click in canister
Push the canister into Thopaz
until you hear aclick.
Use only after instruction by trained personnel.
“pressure“ generally implies “negative pressure”
1
click
Canister secures tubing

EN 9
4
1. Seal offthe conical connector of the patient tubing with your
thumb (through the packaging).
4. Thopas is in standby mode and is ready for use with the
factory settings.
Switch on Thopaz
2. •Switch on pressurewith the “On” button –pressureisbuilt up
•Check flow value
Flow decreases: Thopaz is ready for use
Flow does not decrease: Leak in the system,
Check tubing connections,
replace canister and/or tubing
1. Switch on Thopaz with []–self-test starts
If the self-test is not successful, see the notes for troubleshooting
on the display(Chapter XII)
2. New patient? Yes/No
Ensuretubing is not bent during the function check.
5Conduct functional check
•“Yes” means that Thopazwill issue a
new therapynumber (This is recom-
mended when achange of patient
occurs.)
•“No” means that the therapynumber
remains unchanged (This is recom-
mended for the continued treatment of
the same patient). Therapynumber
3. Change into standby mode: press “Off”button for amin. 3sec.
The therapy number is displayed in the middle of the
navigation field.

In Use
VIII
10 EN
1
Remove the tubing from the inner packaging before
connecting to patient.
In accordance with the physician’sdirections, con-
nect patient catheter to the tubing
Use
3
Thereare two different modes available:
Data mode and Graph mode
Check therapy progress
2
EIN
3. •Switch on pressurewith the “On” button –the pre-selected
pressureisbuilt up and kept constant
•Check flow value
1. Switch on Thopaz with []–self-test starts
The acoustic alarmfunction is deactivated for the first 30
seconds after turning on. During this time the pressureis
built up.
In the data mode, the set pressurevalue and the current flow
value (equivalent to parenchymal leakage) aredigitallydisplayed.
While in the data mode, the graph mode is activated with
“Graph” button. The flow and pressureprogression aredis-
played on atime line. To returntothe data mode, press the
“Data” button or after 60seconds the displaychanges to the
data mode.
Data mode Graph mode
2. New patient? Yes/No
see page 9

EN 11
4Switch off
1. Clamp patient tubing
2. Switch offpressurewith the “Off” button (press for >3sec)
-Thopazchanges into the standbymode
3. Release, remove and seal canister
4. Dispose of canister and patient tubing in accordance
with internal hospital guidelines
5. Switch offThopaz with []
Option: save data –see Chapter X
Graphic representation
The graph shows the flow and pressureover the span of time.
The graph mode offers an informative graph after 4hours of
therapyuse. The graph is updated once everyten minutes.
Up to max. 1000 ml/min or 1l/min aredisplayed in the
graph mode
Flow values
Pressurevalues
Flow
Pressure
Current pressureand flow values
Current time
•The last 24 hours aredisplayed with 0corresponding to the
current time.
•The right scale shows the flow.The flow values arerepresen-
ted as aline.
•The left scale shows the pressureand represented as afilled
space.
•Current flow and pressurevalues aredisplayed in the information
field.

12 EN
Change canister
IX
-onthe basis of avisual check
-according to the instructions in the display /alarm signal
1. Retrieve sterile canister.
2. Clamp patient tubing.
3. Switch offpressurewith the “Off” button (press for >3sec).
Thopazchanges into the standbymode.
4. Release and remove canister.
5. Unpack new canister,position and click into Thopaz.(Chapter VII)
6. “On” Pressureisbuilt up.
7. Unclamp tubing.
8. Check flow value. (> 0ml/min)
9. Seal used canister and dispose of it in accordance with
internal hospital guidelines.
Change settings
X
The settings can only be changed by the physician him/herself or physician order.
Operating mode
Change Pressurewhile pump is running
a) Press the “Off” and “Graph” button as the
same time. The pressurefield will be highlighted.
b) With the selection buttons, choose the desired pressureand confirm with “OK”.
c) To activate the gravitymode (=water seal), skip b) and press []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 apressure of
0.1 kPa /1cmH2O /1mbar /0.75 mmHg.
Press at the same time
9
5
4

EN 13
a) With the selection buttons choose the
desired parameters and confirm with “OK”.
b) With the selection buttons choose the desired setting and confirm with “OK”.
c) With the “Back” button the setting mode is ended, and standbymode is
activated.
Set as standard
Thopazis delivered with the following factorysettings.
These settings can be changed and saved
as the new standardand areactive whenever
Thopazis switched on.
To save the selected setting parameters,
“Yes” for “Set as standard”, press “back”
key to activate standby mode.
Standby mode
Adjust default settings from standby-mode
Press at the same time
Selection
Languages according to list
Display
Display
Display
Selection
max. 100 /10.0
kPa /cmH2O /mbar /mmHg
ml/min /l/min
low /high
No /Yes
cmH2Oisnot aSIunit according
to EU Directive 80/181/EEC

14 EN
Alarms
XII
Thopaz distinguishes between faults/warnings and alarms
If Thopazdetects anyof these situations, an acoustic warning signal sounds and adescription
of the problem appears on the display.Bypressing the two selection buttons simultaneously,
the acoustic alarm is suppressed for 60sec. Hints on troubleshooting appear on the display.
Data transfer to PC
XI
With the softwareThopEasyall data from the treatment can be uploaded to aPCfor docu-
mentation to the patient records. The data can be complemented with patient information,
saved and printed.
The instructions (Read me) for the data transfer and the softwareThopEasyareonthe
Thopaz-CD.
Example:
Internal fault
The problem cannot
be corrected bythe
user.
The fault number is
displayed. beep
Warning
Pressureis
maintained
beep
Alarm
Pressure
cannot be
maintained
beep beep beep
Press at the
same time
Troubleshooting on
the display
Problem description
on the display
Acknowledge
acoustic
alarm
Fault number
✘
✔

EN 15
Fault
number
Problem descrip-
tion on the display
Troubleshooting on the
display
Remarks/potential cause
of fault Pressure
Alarm
305BatteryemptyCharge battery
302System clogged •Check that tubing is
clear/not twisted
•Check canister filling level
•Tubing is kinked or clogged
•Filter in canister contami-
nated
308Tubing clogged Check that tubing is clear/
not twisted
Measuring tubing is kinked
or clogged
301L
eak in system Check system for leaks •Tubing not fixed
•Missing or defective seal
between the canister and
Thopaz
307 Remaining time
=0h
•Replace Thopaz
•Consult instructions for use
•Appears when switched on
•Thopazcannot be set into
operation
•Use new pump
Internal clock error Connect Thopazto PC and
start ThopEasy
•Time wrong because battery
charge is low
•Synchronise with ThopEasy
Warning
401Batterylow Charge batteryRemaining time of battery
approx. 30min.
306Canister full Change canister Pressureismaintained if
Thopazis in upright position
404Leakage •Check patient status
•Check system for leaks
•Check settings (physician)
•Irregularityin the course
of therapy
•Tubing not fixed
•Missing or defective seal
between the canister and
Thopaz
•Change flow range setting
(high/low)
•continue with «OK»
402USB connection
not permitted
Unplug USB cable USB connection during
operation or in patient
environment not permitted
403Remaining time
<200 h
•Start therapywith OK
•Consult instructions for use
•Appears when switching
on and off
•Therapycan be performed
•Order new pump
405Standbymode Switch on or offInstandbymode after
5minutes
Internal fault
Internal fault
XXX
•Switch Thopazoffand on
•Inform Medela Customer
Service
If fault message repeated,
notifyfault number to Medela
Customer Service
✔
✔
✘
✘
✘
✔
✘
✔

Regulation
The pressureischecked periodicallybyThopazand kept constant.
The set pressureisthe same as the pressureofthe entiresystem including the patient.
Safety pressurerelief
The adjustable pressurerange of Thopaz
is 0to -10kPa.
If higher pressurevalues greater than -7kPa areset, the following warning appears in the display:
Toohigh pressurecan cause pain and injuries to the patient.
This warning must be acknowledged with “OK” beforethe pressurecan be increased further.
“Gravity drainage” mode
For patients who aretobetreated using gravitydrainage (= water seal or Buelau drainage) the
minimum adjustable pressure(0.1 kPa /1cmH2O /1mbar /0.75 mmHg) can be selected.
Tubing sets
The tubing sets arepackaged in two sterile bags. The tubing set is comprised of asuction
and ameasuring tubing. From the patient’sperspective the two tubings areconnected with
one another; from the Thopazperspective the patient tubing leads into the suction canister,
the measuring tubing into the measuring sector of Thopaz.Ahydrophobic overflow protection /
bacteria filter in the tubing adapter prevents the contamination of the measuring sector of Thopaz.
Tube flushing
Flushing of the tubing occurs automaticallyevery5minutes and prevents clogging of the pati-
ent tubing.
Safety chamber in the canister
For appropriate, safe operation Thopazmust remain in an upright position during use. If
Thopaztips, the special construction of the safetychamber in the upper region of the canister
protects the hydrophobic filter from prematureclogging. The pressureismaintained.
Important: set Thopazupright again.
When the canister is full and Thopaztips over,the secretions will flow into the safetychamber
and clog the hydrophobic overflow protection /bacteria filter.Inthis case, the pressureisinter-
rupted and an alarm will sound. The canister must be replaced.
Pressurerelief valve in the canister
The pressurerelief valve prevents an unphysiological, intrathoracic pressurepeak during
coughing.
Flow range
The air leak values (flow) aremeasured and averaged constantly.The graph shows the flow and
pressureover the span of time. In case of an straightforwardhealing process the flow decre-
ases over the course of therapy.The values can varywithin apre-defined range without setting
offanyalarms. This ensures that alarms which would be triggered bybrief fluctuations of the
pressurevalues (e.g. through coughing) aresuppressed.
An increase in flow over acertain period of time can be an indicator of leakage in the system or
an irregularityin the course of the therapy.The warning “Leakage” makes the user awareofthis
situation (see Chapter XII). After checking the patient's status and the system, the sensitivityof
“Flow range” can be set from “high” to “low” (see Chapter X) if necessary.
Functions
XIII
Pressurevalue cmH2Ombar mmHg
-7kPa -70-70-53
-10kPa -100 -100 -75
16 EN

EN 17
Housing
Accessoryparts
(Docking station,
carrying strap)
Tubing set
Canister
These aredisposable items and maynot be reused.
Replace after everyuse!
Wipe offwith a
damp cloth.
Wipe offwith
adisinfecting
agent.
Wipe offwith adisinfecting agent.
Sterilisation /cleaning in awashing
machine areNOT permissible.
Cleaning Disinfection Sterilisation Washing machine
✔✘✔✘
Optional Accessories
XlV
Cleaning
XV
Thopaz with accessories should be cleaned /disinfected after everyuse.
General notes
•The internal hospital directives take precedence.
•Dispose of fluids such as blood and secretions and the parts contaminated with them in
accordance with internal hospital guidelines.
•Wear suitable gloves for cleaning /disinfection.
•Unplug Thopazbeforecleaning /disinfection.
079.0031
Carrying strap 079.0032 Docking station
(is delivered without mains adapter)
Classification according to RKI* guideline: non-critical
Disinfection
Thopazcan be disinfected with the disinfecting agent group “alcohol”.
Do not use other cleaning agents (e.g. Terralin) as theycan damage the plastic housing.
Immersion disinfection, thermal disinfection and ultrasound cleaning arenot permitted.
Sterilisation
Thopazand Thopazaccessories cannot be sterilized.
*Robert Koch Institute
079.0034
USB –Cable
Standard
( not contained in deliverypackage)

18 EN
Thopazis operable while connected to the mains power supplyor bythe internal re-charge-
able lithium-ion battery.While in use and connected to the mains power supply,the batteryis
re-charged.
The charge on the batteryis dependent upon the run-time of the pump (see Chap XVII). This
is influenced bythe extent of parenchymal leakage and the set pressure. It onlyruns when
thereisadifference between the set and current pressure.
If Thopazis running continuously,Medela guarantees amaximum of 4hours of batterybefore
it is necessaryto re-charge. This case will not be encountered in practice; the real expectant
charge of the batteryexceeds 10hours.
If Thopazhas not been in use, the batterymust be charged approximatelyonce every6months
to ensureoptimum functioning.
Backup battery
If adefect occurs (broken cable, batterydefective), an acoustic warning is sounded for at
least 3min. The power is supplied bythe backup battery.Replace Thopazimmediately.
Batteriemanagement
Xl Power supply/battery management XVI
Medela guarantees arun-time of 4000 hours. Thopazmust be replaced then. The remaining
run-time is automaticallychecked everytime the device is turned on and can be controlled in
the mean settings 2/2.
Effective run-time
The run-time refers to the effective operation of the motor,not to the operating time.
The run-time does not correspond to the duration of treatment.
Thopazbuilds up the set pressureand keeps it constant. This means that Thopazis not run-
ning constantly,but onlyturns on when the measured pressureislower than the set pressure.
Possible displays when the device is switched on and /oroff (See Chapter XII)
Service life
XVll