Vario Series Instructions for Use

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Congratulations

You have purchased a high quality secretion aspirator. The QuatroFlex™ suction aggregate is the innovative continuation of the proven Medela piston / cylinder system. User-friendliness, simple cleaning and safety features are additional advantages of these versatile secretion aspirators. A comprehensive range of accessories makes the Vario 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 Vario is highly suitable for the aspiration of surgical fluids, secretions, tissue (including bone) and infectious particles. In the emergency room, the doctor's practice, the ward or in the home care area. Please make sure you have the correct Vario version for the required application. Vario 8

Vario 8 AC/DC

Vario 8 c/i* AC/DC

Vario 18

Vario 18 AC/DC

Vario 18 c/i* AC/DC

General suction purposes Thoracic healing Wound healing ENT indications Gastric suction *c = constant suction / i = intermittent suction

An extensive range of accessories makes the Vario the ideal device for a broad range of medical applications. Contact us – we will be pleased to advise you.

lll Safety instructions Correct and safe operation only with Medela accessories Read all safety instructions before use • For use only by medically trained persons who have been adequately trained in suction procedures and in the use of aspirators. Caution: incorrect use can cause pain and injury to the patient. • Before you plug in the device, please check that your local power supply is the same as the voltage given on the specification plate. • 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 perfectly - If the device is damaged - If the device shows clear safety defects.

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• The overflow protection/bacteria filter protects the pump against overflow. Caution: Suctioning is interrupted when the filter is wet/moist or clogged. Test the filter before each use and during use periodically. (Filter test chapter X) • The pump must stand upright during use. • 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. A sterile suction catheter must always be used (risk of infection). • In the case of overflow, inform the internal technical service immediately and perform the tasks in the service manual. • Keep the power cord away from hot surfaces. • The plug and the ON/OFF switch must not come into contact with moisture. • Separation from the mains 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 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 leave the device unattended when it is switched on. • Never place the device in water or other liquids. • The Medela Vario 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. Portable and mobile RF communications equipment can affect medical devices.

Indications Thoracic drainage

For thoracic drainage, the Vario 8 must be used in combination with components of the Medela Thorax Drainage System (disposable canister, trolley). Otherwise Medela cannot guarantee a safe function of the system.

Wound healing

If the Vario is used for wound healing, care must be taken to ensure that the wound has not dried out and that the bandage is firmly in place. If an unusually large amount of fluid collects in the suction jar (excessive loss of blood), the wound drainage must be stopped.

Gastric suction

Only with Vario 18c/i: When the device is used for gastric suction, the patient’s condition and correct functioning of the pump (on the basis of acoustic and visual signs) must be checked at least once every four hours. For patients for whom a breakdown of the device can lead to a critical situation (e.g. patients with acute dyspnoea or severe catarrhal congestion), a replacement device must always be available.

ENT indications

These Instructions for Use must be kept for later reference.

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lV Guarantee Two years guarantee for the device, and six months guarantee for the rechargeable battery and the Quatroflex™ suction 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.

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Operating elements Vacuum gauge

Vacuum regulator

Class 2.5 DIN 16005

Press knob to turn

only for AC/DC versions:

LED for battery operation

On/Off switch

c/i versions

Other elements (see inside of cover): c

Adaptor (lateral) for second suction jar

d

Adaptor (at front) for suction jar

e

Housing of the device

f

Handle

g

Tube holder

h

12 V DC connector socket (only AC/DC models)

On the bottom of the device:

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i

Exhaust

j

Specification plate

k

Fuse

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Vl Accessories Correct and safe operation only with Medela accessories Contained in the delivery package a

077.0931

Silicone tubing with coupling and angle pieces

b

077.0571

Overflow protection / bacteria filter (5 pcs)

Optional accessories – not contained in the delivery package Reusable system

☛ 077.0110

1-litre suction jar PSU

077.0120

2-litre suction jar PSU

077.0155

0.5-litre suction jar PSU

077.0420

Large lid, conical patient connection

077.0440

Small lid, conical patient connection

Disposable system (only for Vario 18)

☛ 077.0211

1-litre suction jar PC

☛ ☛ 077.0311

1-litre disposable suction bag with solidifier

077.0221

077.0310

☛

2-litre suction jar PC 1-litre disposable suction bag

077.0320

2-litre disposable suction bag

077.0321

2-litre disposable suction bag with solidifier

077.0410

Lid for disposable suction bag

General accessories

☛ 077.0951 077.0821

Disposable tubing with fingertip ø 8.3 x 5.9 mm, char. 25, length 180 cm Rail holder

077.0823

Universal holder

077.0824

Trolley plate

077.0825

Rail holder for thoracic drainage

077.0826

Holder for disposable canister

077.0831

Carrying bag

077.0832

Car connection cable for 12 V DC

Other accessories available on request – We will be pleased to advise you.

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Vll AC/DC versions Visual

Indicators

Acoustic

during battery operation does not light up During mains operation

rechargeable battery is fully charged

blinks slowly

rechargeable battery soon empty

lights up

rechargeable battery is being charged

does not light up

rechargeable battery is fully charged medium vacuum

high vacuum

Performance of rechargeable battery

low vacuum

Duration of pumping

~120 Mins. ~ 30 Mins.

~ 30 Mins.

Charging time (charged up to 100%)

~ 5 Hrs.

~ 5 Hrs.

~ 5 Hrs.

low vacuum

medium vacuum

high vacuum

-90 mbar - 9 kPa -68 mmHg

-55 kPa -413 mmHg

-55 kPa -413 mmHg

> 120 Mins. > 30 Mins.

> 30 Mins.

Rechargeable battery is charged during mains operation.

Testing of rechargeable battery 1. 2. 3. 4. 5. 6.

Pull out mains plug Set required vacuum Plug the suction port Switch on the Vario Measure the running time Compare the running time

ok?

OK, if the above values are reached

not OK • Repeat the test • Calibrating the rechargeable battery

NiMH rechargeable battery

Before first use

Calibrating the rechargeable battery A Completely discharge the rechargeable battery • Disconnect the mains cable • Switch on the Vario and allow to run until it comes to a standstill B Charge the Vario • Plug in the mains cable – the rechargeable battery is being charged • Wait until the charging indicator goes out

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Repeat this process once The Vario is then ready for use

Operation with rechargeable battery

☛ Only charge the rechargeable battery when the acoustic signal sounds and the charging indicator blinks slowly

Storage

In order to keep the self-discharge at a minimum, store the Vario and the replacement rechargeable batteries at temperatures below 25°C (77°F). Repeat Steps A and B every 60-90 days

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Vlll Application 1. Check general condition of the device • Is the overflow protection / bacteria filter present and OK? (Test – see Chapter X) Change the filter… • once a week • after an overflow • when there is a change of patient • Check seal of tubing connections • Suction jars and lids – Check for cracks, brittle areas, discolouration? – exchange, if necessary • Mechanical overflow protection must be open

2. Test function a. Switch the device on • AC/DC and c/i versions: before first use, charge the rechargeable battery for five hours • AC versions: plug in • With AC/DC and c/i versions, select continuous pumping mode b. Set maximum vacuum Press knob to turn

c. Attach patient tubing and clamp tubing d. Compare vacuum + 2000 m +1000 m + 500 m 0m

ok?

low vacuum

medium vacuum

high vacuum

– 7,0 kPa – 7,9 kPa – 8,5 kPa – 9,0 kPa

– 43 kPa – 48 kPa – 51 kPa – 55 kPa

– 59 kPa – 66 kPa – 70 kPa – 75 kPa

not OK, see Chapter XI

OK 3. Use Select correct vacuum and suction mode according to the particular application) Press knob to turn

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lX Cleaning Disconnect the device before cleaning • 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

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Test filter Filter open! 1. Select maximum vacuum 2. Switch on the Vario 3. Read / compare the vacuum

Vario 8 low vacuum

Vario 18 medium vacuum

Vario 18 high vacuum

- 3 kPa

- 10 kPa

- 10 kPa

If the mentioned values are exceeded, the filter must be replaced.

Xl Troubleshooting Insufficient vacuum

Check • Setting of the vacuum regulator • Condition of the tubings • Seal of the tubings connections • That the overflow protection is functioning correctly • If the filter is blocked • Examine the suction jars, lids and seals for blockages / brittle areas

Motor not running

Check • Is mains/battery power present? • Is the device switched on? • Is the fuse ok? Replace fuses according to the specification plate Before changing the fuses, it is essential to disconnect the pump from the mains supply!

c/i versions

Check the interval times • Check the jumper setting • Correct position of the On/Off switch

On

8 Secs.

Off

4 Secs.

16 Secs. 8 Secs. 32 Secs. 16 Secs. If the fault cannot be corrected, contact the internal technical service

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Xll Service work / Settings Corresponding illustrations are to be found on the back flap. •

Disconnect the pump from the mains supply

•

Remove four screws

•

Remove cover

the A1 Detach the battery cable A Replacing rechargeable A2 Remove the rechargeable battery battery A3 Insert new rechargeable battery 077.0833 A4 Attach battery cable

Replacing B1 Remove the three tubings B QuatroFlex™ B2 Turn QuatroFlex™ 45° to the left 600.0491 B3 B4 B5 B6 B7

C

Remove QuatroFlex™ Clean inside of the pump Insert QuatroFlex™ Turn QuatroFlex™ 45° to the right Re-attach all the tubings

Set interval C1 Determine the slot required times C2 Attach jumper in required position

On

8 Secs.

Off

4 Secs.

16 Secs. 8 Secs. •

Attach cover

32 Secs. 16 Secs.

•

Insert four screws

•

Plug the pump in

•

Only for AC/DC versions: charge the rechargeable battery for five hours

•

Test functions

Xlll 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)

XlV Disposal The Vario is made from various metals and plastics. Before disposal, the device is to be rendered unusable and it must be disposed of in accordance with the local regulations. With the AC/DC versions, the electronic components and the rechargeable batteries must be disposed of separately, in accordance with the local regulations.

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Notes

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Notes

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Notes

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