Dominant 35 c & i Instructions for Use June 2009

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l 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, dependable 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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Intended use

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).

lll Safety instructions 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 environment 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 gastrointestinal 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 Customer 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 EN

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• 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.

IV Safety-related checks 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 leakage 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 functional earth connections.

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Guarantee

5-year warranty from the date of delivery for the unit. The manufacturer is not liable for any damage 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. Guarantee service is available with proof of purchase from the original purchaser.

VI Operating elements – Dominant 35 c/i See inside of cover: a b c d e f

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

VII Important notes In the application area of medical suction devices, the vacuum is normally quoted asthe difference (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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VIII Functional test 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.

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Switch the device on using the "C" button or by pressing down on the foot on/off switch

b. Set maximum vacuum.

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Attach patient tubing to the aspirator, cover end of tubing with your thumb.

d. Compare vacuum + 2000 m + 1000 m + 500 m 0

ok? OK

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not OK, see Troubleshooting

Minimum values – 59 kPa – 66 kPa – 70 kPa – 75 kPa

– 443 mmHg – 495 mmHg – 525 mmHg – 563 mmHg

3. constant

Use flow: 35 l/min.

intermittent flow: 8 l/min. * Default: Or set On-time

On-time: 16 sec. Off-time: 8 sec. 0:05 – 5:00 (min:sec)

hold…

Off-time

…and set

0:05 – 5:00 (min:sec) hold…

…and set

* you may change values first, but then press "i" within 3 minutes Select correct vacuum according to the particular application

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IX Cleaning and Sterilization 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

6g 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

pump housing power cord

cleaning

disinfection

sterilization

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 recommend 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.

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Troubleshooting

Motor not running

Check • Voltage • c/i mode activated • Fuse

Insufficient vacuum Check • Position of regulator • Tubing • Plug-in connections • Overflow protection device • Suction jars and lids – Check for cracks, brittle areas, discolouration If the fault cannot be corrected, contact the internal technical service or your service center.

XI Routine Check 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)

XII Disposal 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.

XIII Occupational safety and health Guideline for Service Workshops of Medela and Representatives We strongly recommend workshop personnel and other staff working on potentially contaminated 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.

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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.

XIV Accessories 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.

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Notes

Notes

Notes

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©Medela AG/200.0682/06.09/C

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