Medela Dominant 35 c/i User manual

EN Instruction for use
DE Gebrauchsanweisung
FR Mode d’emploi
IT Istruzioni per l’uso
NL Gebruiksaanwijzing
SV Bruksanvisning
FI Käyttöohjeet
DA Brugsanvisning
NO Bruksanvisning
ES Instrucciones de uso
Dominant 35 c/i

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EN 11
The Dominant 35 c/i is intended to be used for a variety of suctioning procedures in the constant
suction mode including nasopharyngeal, tracheal, surgical, wound and thoracic drainage (must
be used only in combination with a chest drainage unit with a built in suction valve).
Intended usell
The Dominant 35 c/i is a high-quality secretion aspirator developed for medical applications. Its
well-proven piston/cylinder system guarantees maximum suction performance and quiet, depen-
dable operation. The Medela Dominant 35 c/i is user-friendly, requires only simple cleaning and is
safe and effective for negative pressure wound therapy.
A comprehensive range of accessories makes the Dominant 35 c/i ideally suited to a wide range
of medical applications. Contact us – we will be pleased to advise you!
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Safety instructionslll
Functional test must be performed after each patient.
(See Functional test)
For correct and safe operation, use only Medela accessories.
Read all safety instructions before use.
Warnings
• Warning! For use only by medically trained persons who have been adequately trained in
suction procedures and in the use of aspirators. Only for medical suction purposes. Incorrect
use can cause serious injury.
• Beforeyoupluginthedevice,pleasecheckthatyourlocalpowersupplyisthesameasthe
voltagegivenonthespecificationplate.
• Neverplacetwocontainersatonesideonly(leftorright),especiallyfortransportation.
• Thedevicemustnotbeusedforsuctioningexplosive,easilyflammableorcorrosiveliquids.
• Theconnectingtubingsuppliedwiththedevicemustnevercomeintodirectcontactwiththe
suction area.
• Neverusethedeviceathighroomtemperatures,whilebathingorshowering,orinanenviron-
mentwherethereisariskofexplosion,inMRIsorCTs.
• Whenoperatingintheintermittentmodedonotsetlongperiodsofsuctioningin"ON"time
andshortbreakperiodsin"OFF"time(e.g.ONtime5min./OFFtime5sec.)forgastrointesti-
nalsuctionprocedures,becausethiswouldbeequaltosuctioningintheconstantmode.
• Pullthepowersupplyplugoutofthesocketbeforecleaningthedevice.
• Ineachofthefollowingcases,thedevicemustnotbeusedanditmustberepairedbyCusto-
mer Services:
 –Ifthepowercableortheplugaredamaged
 –Ifthedeviceisnotfunctioningproperly
 –Ifthedeviceisdamaged
– If the device shows clear safety defects.
Precautions

2EN
• Thepumpmuststanduprightduringuse.
• TheMedelaDominant35c/iisamedicaldevicethatrequiresspecialsafetymeasuresin
regardtoEMCandmustbeinstalledandputintooperationinaccordancewiththeattached
EMCinformation.
• PortableandmobileRFcommunicationsequipmentcanaffectmedicaldevices.
• ThisdevicecomplieswithIEC60601-1-2:«Medicalelectricalequipment-Electromagnetic
compatibility»andistherefore unlikely to interfere with other electrical equipment.Incase
thereisinterference(whichcanbedeterminedbydisconnectingthedevicefromthemains
supply),trythefollowing:Reorientingorrelocatingthedevicewithrespecttotheotherdevice
orconnectingthedevice'spowercordtoanotherpoweroutlet.
• Inthecaseofoverflow,informtheinternaltechnicalserviceimmediatelyandperformthetasks
in the service manual.
• Keeppowercordawayfromhotsurfaces.
• TheplugandtheON/OFFswitchmustnotcomeintocontactwithmoisture.
• Separationfromtheelectricpowersourceisonlyassuredthroughthedisconnectionofthe
plugandsocketconnection.
• Neverpulltheplugoutofthemainssocketbypullingontheconnectingcable!
• Neverleavethedeviceunattendedwhenitisswitchedon.
• Neverplacethedeviceinwaterorotherliquids.
• Check the patient’s condition as well as the proper running of the pump (by means of
audibleindicationsandvisualsigns)accordingtohouse-internalguidelinesoratleastevery
four hours.
TheseInstructionsforUsemustbekeptforlaterreference.
Safety-related checksIV
For the safety-related checks, it is assumed that the device is maintained and repaired throughout
its service life in compliance with the Service procedures.
For the Dominant 35 c/i as a device in protection class II (EN IEC 60601-1, A1, A2:1995), the
safety-related checks are confined to visual inspection of the housing and main power cord for
damage. This check must be performed prior to each use.
Devices of protection class II do not have a protective earth conductor; there is therefore no need
to check the earth leakage current!
The Dominant 35 c/i enclosure is made entirely of insulating material. Tests of the enclosure lea-
kage current using common measuring instruments will therefore not reveal measurable values.
The applied parts of the Dominant 35 c/i are connected to the Dominant 35 c/i via non-conductive
vacuum tubing, collection jars and intermediate tubings.
Even when suctioning a conductive fluid until the overflow protection device activates (9 g/l NaCl;
EN ISO 10079-1;1999), measurements of the patient leakage current using common measuring
instruments will not reveal measurable values.
The Dominant 35 c/i pumps do not have patient circuits, signal input and output parts and func-
tional earth connections.

EN 3
GuaranteeV
5-year warranty from the date of delivery for the unit. The manufacturer is not liable for any da-
mage or consequential damage caused by incorrect operation, inappropriate usage as well as
use by unauthorized persons. Routine inspections and servicing work must only be carried out
by personnel authorized by Medela.
This guarantee does not apply to parts that have been damaged by accident, alteration, misuse,
abuse, neglect, improper maintenance, vandalism, fire, theft, water, terrorism, acts of God or war,
or damage because of peril or other natural disaster.
Guarantee does not cover normal wear and tear expected on components including motor. Gu-
arantee service is available with proof of purchase from the original purchaser.
Operating elements – Dominant 35 c/iVI
Silicone tubing
Suction jar, PSU, 1 Liter (optional)
Holder for jar
Operating elements
Standard rail
Castors with brakes
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Foot on/off switch – Activating the
pump with this switch causes operation
in constant mode - high flow
Standby LED
Vacuum gauge Class 2.5 DIN 16005
Vacuum regulator
Safety device
See inside of cover:
Important notesVII
In the application area of medical suction devices, the vacuum is normally quoted asthe diffe-
rence (in absolute figures) between the absolute pressure and the atmospheric pressure or as
negative values in kilopascals (kPa).
The indication, e.g. of -10 kPa, in this document therefore always refers to a pressure level in kPa
below the ambient atmospheric pressure.
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4EN
Functional testVIII
1. Check general condition of the device
(Accessories shown here:
1-litresuctionjar(reusable)
Largelid,conicalpatientconnection
Check
• Is the safety device attached properly
• Check seal of tubing connections
• Suction jars and lids – Check for cracks, brittle areas,
discolouration? – Exchange, if necessary
Mechanical overflow protection must be open.
Pull downward
2. Test function
Check to ensure there is sufficient vacuum.
a. Switch the device on using the "C" button or by pressing down
on the foot on/off switch
b. Set maximum vacuum.
c. Attach patient tubing to the aspirator, cover end of tubing
with your thumb.
not OK, see Troubleshooting
ok?
OK
–443mmHg
–495mmHg
–525mmHg
–563mmHg
–59kPa
–66kPa
–70kPa
–75kPa
d. Compare vacuum Minimum values
+ 2000 m
+ 1000 m
+ 500 m
0

EN 5
3. Use
flow: 35 l/min.
flow: 8 l/min.
Default: On-time: 16 sec.
Off-time: 8 sec.
Or set
On-time 0:05 – 5:00 (min:sec)
Off-time 0:05 – 5:00 (min:sec)
* you may change values first, but then press "i" within 3 minutes
Select correct vacuum according to the particular application
hold… …and set
hold… …and set
*
constant
intermittent

6EN
Cleaning and SterilizationIX
After each use all parts that contact suctioned fluids must be cleaned, disinfected, sterilized or
disposed. Before cleaning the device, unplug the pump from the wall outlet.
• Comply with in-house directives on hygiene.
• Clean the device with a damp cloth and with non-aggressive cleaning material.
• Suction jars, lids, suction bags and other accessories are to be handled in accordance with
the instruction-sheets provided.
• Fluids (blood, secretions…) and contaminated parts must be disposed of in accordance with
facility requirements.
• Empty canister regularly, by pulling upwards out of the holder
Medela recommends these surface cleaning agents:
Disinfectant Active ingredients Amount
in 100 g
Manufacturer
Hexaquart
plus
(aldehydefree)
[concentrate]
Didecldimethylammonium chloride
Lauryldipropylene triamine
Biaguanidine acetate
6 g
5.5 g
4.2 g
B. Braun Medical AG
www.bbraun.ch
Perform
[concentrate]
Potassium peroxomonosulphate
Sodium benzoate
Tartaric acid
Non-anionic surfactants
Soap phosphate
Perfumes
20 g
15 g
10 g
5 – 15%
5 – 15%
< 5%
Schülke & Mayr
www.schuelkemayr.com
cleaning disinfection sterilization
pump housing
power cord
4 with damp cloth 4 with disinfection
agent (such as above)
8 not autoclavable
Cleaning of suction canisters and lids (PSU and PC): For optimal user-safety, we recom-
mend checking the suction canisters and lids before each use as natural damage may occur
over time. This is done by checking the parts optically and evacuating the suction canisters to a
maximum vacuum. Defect suction canisters and lids must be replaced.
Polysulfone (PSU) canisters: Disinfect and sterilize at 134°C/273°F for 10 minutes.
Remove any chemical disinfectant residue before autoclaving. Do not stack during autoclaving.
Do not use any cleaning agents based on phenol. When used appropriately, the suction canisters
and lids have a life time rating of 2 years or 200 autoclavings (for PSU).
We recommend to replace the suction canisters and lids after this period for safety reasons.
Polycarbonate (PC) canisters: Do not autoclave. Maximum temperature for disinfection is
100°C/212°F. Do not exceed concentrations, soaking times or temperatures recommended by
manufacturer.
Silicone tubing: Tubing is autoclavable at 134°C/273°F for 10 minutes.

EN 7
Routine CheckXI
Routine checks and service work may only be carried out by Medela authorized personnel. The
routine check is to be carried out once a year (see Service Manual)
Check
• Voltage
• c/i mode activated
• Fuse
Check
• Position of regulator
• Tubing
• Plug-in connections
• Overflow protection device
• Suction jars and lids – Check for cracks, brittle areas,
discolouration
Motor not running
Insufficient vacuum
TroubleshootingX
If the fault cannot be corrected, contact the internal technical service or your service
center.
DisposalXII
Before disposal, the device is to be rendered unusable and it must be disposed of in accordance
with the local regulations. Hand the discarded device to a local collection and recycling center
for old electrical and electronic appliances. Incorrect disposal can have harmful effects on the
environment and public health.
Occupational safety and healthXIII
Guideline for Service Workshops of Medela and Representatives
We strongly recommend workshop personnel and other staff working on potentially contamina-
ted equipment to be vaccinated against hepatitis B.
Carefully consider further protection provided by vaccination and other precautionary measures
which may be advisable in your region.
When devices are returned to service centers for repairs, the device/componentsare to
be considered hazardous and potentially infectious.
Such equipment shall be separated, marked accordingly and be stored in an isolated location
until disinfection.

8EN
Disinfection Procedure:
• Always wear suitable work clothing, protective gloves and goggles.
• Unpack equipment and place it on a suitable bench (sink).
• Open device and dispose of any soiled, contaminated parts like internal tubing, valve plates,
etc. according to local regulations.
• Disassemble piston/cylinder units which are not worn out.
All possibly contaminated parts:
1. Spray the surfaces with hospital spray disinfectant and leave for 3 minutes.
2. Clean the surfaces with a good cleaning agent, methodically rinse with water.
3. Again spray the exterior with disinfectant and wipe parts dry with household tissue or
allow to air dry.
• Dispose of protective gloves after the disinfection procedure.
• Wash your hands.
AccessoriesXIV
For correct and safe operation, use only Medela accessories.
Optional accessories – not contained in the delivery package
Reusable system
077.0110 1-liter suction jar - PSU (autoclavable)
077.0420 Large lid, conical patient connection
077.0440 Small lid, conical patient connection
Disposable system
077.0211 1-liter suction jar - Polycarbonate
077.0310 1-liter disposable suction bag (requires PC canister)
077.0311 1-liter disposable suction bag with solidifier (requires PC canister)
077.0410 Lid for PC canister for use with disposable suction bag
Other accessories available on request. We will be pleased to advise you.