Users Manual
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USER’S MANUAL
VAVD CONTROLLER
Copyright All rights reserved. No part of this publication may be duplicated, adapted or translated without prior written permission, except within the framework of the copyright laws. © Copyright MAQUET Cardiopulmonary AG Subject to technical changes Owing to our policy of continuous product development, the illustrations and technical data contained in this may differ slightly from the current version of the device. Manufacturer MAQUET Cardiopulmonary AG Kehler Straße 31 76437 Rastatt GERMANY Phone: +49 7222 932-0 Fax: +49 7222 932-100 [email protected] www.maquet.com
VAVD CONTROLLER | User’s Manual | Multilingual | XX-07 Copyright MAQUET Cardiopulmonary AG
| 8 | 1 General information | VAVD CONTROLLER |
English
EN
VAVD CONTROLLER 1
GENERAL INFORMATION The VAVD CONTROLLER is a mechanical regulator for adjusting the vacuum in an airtight venous reservoir together with vacuum-assisted venous drainage (VAVD). The VAVD CONTROLLER and the reservoir are connected with a sterile tubing set. The tubing set is a sterile disposable product with an integrated moisture trap. It prevents moisture or liquid penetrating the VAVD CONTROLLER. The VAVD CONTROLLER has inbuilt safety valves for negative and positive pressure.
1.1
INTENDED USE The VAVD CONTROLLER is intended to regulate and supply a controllable vacuum of between 0 and -100 mmHg to a sealed venous reservoir during extracorporeal circulation procedures.
1.2
CONTRAINDICATIONS When the VAVD CONTROLLER is used as recommended, and for the specified intended use, there are no currently known contraindications.
2
SAFETY
2.1
SPECIAL INSTRUCTIONS These special instructions are contained in the User’s Manual. Please bear them in mind. WARNING! Risk of serious personal injury! This is an instruction or procedure which must be observed to avoid injury to the user, patient or other persons. CAUTION! Risk of damage to device! This is an instruction or procedure which must be observed to avoid the device being damaged. Notice Important or explanatory information.
VAVD CONTROLLER | User’s Manual | Multilingual | XX-07 Copyright MAQUET Cardiopulmonary AG
| 2 Safety | VAVD CONTROLLER |
PRECAUTIONARY MEASURES
EN
2.2
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WARNING! The VAVD CONTROLLER must only be operated by qualified personnel who have read and understood this User's manual. Only use an airtight venous reservoir with an excess pressure safety valve. The reservoir must be able to maintain a vacuum of up to -100 mmHg. Ensure that the venous drainage catheter and the venous return flow tube are long enough and correctly fitted in order to guarantee a constant optimum venous return flow. Two-stage catheters with a large lumen diameter may lead to increased suction in venous drainage. Take special care when using such catheters. MAQUET recommends monitoring the central venous pressure constantly. The vacuum affects the operation of all open lines that are connected to the venous reservoir for discharging, sampling and transporting fluid. Ensure that they work constantly and reliably by taking appropriate action. Ensure that the inlet and outlet tubes are always open and not kinked. If moisture, liquid or blood has got into the VAVD CONTROLLER, stop the VAVD CONTROLLER immediately and have it tested and serviced ( 7.3 “Repair”, page 15). If the VAVD CONTROLLER was exposed to hard knocks or strong blows or if it was handled incorrectly, check the accuracy of the integrated pressure gage using a calibrated pressure gage. Only store and operate the VAVD CONTROLLER under the specified ambient conditions ( “Ambient conditions”, page 16). Other ambient conditions may damage the control and safety functions. There must be no risk of condensation. Condensation may occur when the device is taken from a cold environment into a warm room. CAUTION! In accordance with US federal law this device may only be sold to a physician or on the direction of a physician.
VAVD CONTROLLER | User’s Manual | Multilingual | XX-07 Copyright MAQUET Cardiopulmonary AG
EN
| 10 | 3 Components | VAVD CONTROLLER |
3
COMPONENTS 1
2
3
Front: [1] Pressure gage [2] Vacuum controller ( 5.2 “Adjusting the vacuum”, page 14) [3] On/Off switch ( 5.1, page 14)
1
2
3.1
3
4
Back: [1] "RES" connection (connection to the venous reservoir) [2] "VAC" connection (connection to the vacuum source) [3] Ventilation holes [4] Locking knob ( 4.1 “Setting up the VAVD CONTROLLER”, page 11)
SYMBOLS Rating plate Caution! Observe the warnings and safety precautions given in the accompanying documentation. Observe the instructions in the User’s Manual Reference number Serial number Date of manufacture: Year in which the device was made.
Manufacturer in terms of the Council Directive 93/42/EEC concerning medical devices Do not dispose of the device with normal domestic waste. Keep separate from domestic waste and dispose of in an environmentally safe way in compliance with local regulations.
VAVD CONTROLLER | User’s Manual | Multilingual | XX-07 Copyright MAQUET Cardiopulmonary AG
| 11 |
Rating plate The device meets the requirements of Council Directive 93/42/EEC concerning medical devices. Connections Connection to the venous reservoir Connection to the vacuum source
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PREPARING APPLICATION
4.1
SETTING UP THE VAVD CONTROLLER CAUTION! Place the VAVD CONTROLLER securely on a table or onto a vertical pole using a bracket. Ensure that the tensile strain of the tubes cannot change the position of the VAVD CONTROLLER. FIXING THE VAVD CONTROLLER TO THE POLE 1 Undo the locking knob [1] on the pole retainer [2]. Position the holder so that the pole fits into the pole retainer and screw the locking knob [1] tight. 2 Align the shaft [3] as required and tighten the locking knob [4].
1
2
3 4
3 Fix the shaft onto the VAVD CONTROLLER from the bottom and tighten the locking knob on the back of the VAVD CONTROLLER. Ensure that all screws are tightened and that the VAVD CONTROLLER and the holder are securely fixed. To remove the VAVD CONTROLLER and the holder, follow the same procedure in reverse order.
VAVD CONTROLLER | User’s Manual | Multilingual | XX-07 Copyright MAQUET Cardiopulmonary AG
EN
| 4 Preparing application | VAVD CONTROLLER |
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| 12 | 4 Preparing application | VAVD CONTROLLER |
4.2
CONNECTING AND TESTING THE VAVD CONTROLLER WARNING! Heed the requirements for the vacuum source ( “Vacuum source requirements”, page 16). If the negative pressure is too high, this will impair the operation of the VAVD CONTROLLER. Use a sterile tubing set with an integrated moisture trap each time you use the controller. Ensure that all tube connections to and from the venous reservoir are airtight and secure. 1 Connect the vacuum source and the VAVD CONTROLLER's VAC connection to a 1/4" connection tube. Attach the tube in such a way that it remains open and does not kink when it is exposed to negative pressure. 2 Attach the sterile tubing set with integrated moisture trap to the VAVD CONTROLLER's RES connection. Mark the tube as the connection between the VAVD CONTROLLER and the venous reservoir. 3 Clamp the reservoir end of the tube. 4 Set the On/Off switch to [OFF]. 5 Set the vacuum controller so that the pressure gage indicates a vacuum of -60 mmHg. If a vacuum of -60 mmHg is not reached, check the vacuum source and the tube connections between the vacuum source and the VAVD CONTROLLER. 6 When the pressure gage indicates a vacuum of -60 mmHg, turn the On/Off switch to [ON]. Check that the vacuum of -60 mmHg is maintained. If the vacuum is not maintained, check that there are no leaks in the tubing set and the moisture trap. 7 Open the clamp on the tubing set. Check that the vacuum indicated falls to 0 mmHg. 8 Close the clamp on the tubing set again. Check that the vacuum indicated increases to -60 mmHg again. 9 Turn the On/Off switch to [OFF]. 10 Connect the sterile tubing set to the venous reservoir with a suitable connector.
VAVD CONTROLLER | User’s Manual | Multilingual | XX-07 Copyright MAQUET Cardiopulmonary AG
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11 Set the vacuum required for the start of venous drainage and remove the clamps from the tubing set. 12 Clamp all tubes that are connected to the venous reservoir and close all open connections. Note whether the vacuum level is maintained when the On/Off switch is [OFF]. If this is not the case, check the venous reservoir and the connections for leaks. 4.3
CHECK BEFORE EVERY USE Ensure that the requirements for the vacuum source have been met ( “Vacuum source requirements”, page 16). Ensure that the tube to the reservoir is connected to the RES connection. Ensure that the tubes connected to the reservoir are not kinked. Ensure that the inlet and the outlet are working properly. Ensure that no blood has been sucked out of the reservoir. This could block the valves. Ensure that the inlet and outlet have not been confused because they have been labeled wrongly. Ensure that the vacuum controller is working properly and that the set vacuum is applied at the reservoir in order to avoid excessive pressure in the reservoir. Ensure that the membrane on the VAVD CONTROLLER is rigid, tight and impermeable.
5
APPLICATION WARNING! Check the VAVD CONTROLLER as described before each use ( “Check before every use”, page 13).
4.3
Ensure that the ventilation holes are not covered. Close all roller pumps that pump blood to or from the venous reservoir. Ensure that all tube connections and connections between the reservoir and the pumps are firmly connected and airtight. If you use other pumps to pump blood from the venous reservoir, ensure that they are suitable for use with the VAVD CONTROLLER and that they are reliable.
VAVD CONTROLLER | User’s Manual | Multilingual | XX-07 Copyright MAQUET Cardiopulmonary AG
EN
| 5 Application | VAVD CONTROLLER |
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| 14 | 6 Cleaning and disinfecting | VAVD CONTROLLER |
5.1
ON/OFF SWITCH You use the On/Off switch to specify whether the venous reservoir is connected to the vacuum source or the atmospheric air: Position [ON]: Connected to the vacuum source The VAVD CONTROLLER maintains the selected vacuum level – regardless of the blood flow and the blood level in the reservoir. Position [OFF]: Connected to atmospheric air There is no vacuum applied to the reservoir. WARNING! Switch either [ON] or [OFF] Ensure that the switch is not between [ON] and [OFF]. If this is the case, the venous reservoir would be connected to the atmospheric air and the vacuum.
5.2
ADJUSTING THE VACUUM With the vacuum controller, you can adjust the vacuum in the reservoir infinitely: Turn clockwise: Reduce vacuum Turn anti-clockwise: Increase vacuum The pressure gage indicates the vacuum in the reservoir. Pressure gage needle vibration The pressure gage needle vibrating shows that the low pressure safety valve is open.
5.3
AFTER END OF THE APPLICATION CAUTION! If the VAVD CONTROLLER is not being used, cover the connections on the back with caps.
6
CLEANING AND DISINFECTING
6.1
CLEANING AND DISINFECTING AFTER EACH USE CAUTION! Cover the connections on the back with caps before cleaning the device. Clean the surface of the VAVD CONTROLLER after each use. Use a damp cloth or a sponge to do this and a disinfecting cleaning agent (bactericide, viricide, fungicide). When doing this obey the manufacturer's diluting instructions.
VAVD CONTROLLER | User’s Manual | Multilingual | XX-07 Copyright MAQUET Cardiopulmonary AG
7
MAINTENANCE AND AUTHORIZED SERVICE
7.1
MAINTENANCE BY THE OPERATOR
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The VAVD CONTROLLER cannot be serviced by the user. 7.2
INSPECTION AND MAINTENANCE BY AUTHORIZED SERVICE PERSONNEL The regular inspection and maintenance by authorized service personnel includes, amongst other things, a safety check and the replacement of important parts using a maintenance kit. CAUTION! The inspection may only be carried out by a service technician authorized by MAQUET. Have an inspection and service carried out by authorized service personnel every 12 months ( 7.4 “Authorized service”, page 15).
7.3
REPAIR Repairing restores the proper function of the device. CAUTION! Repairs may only be carried out by a service technician authorized by MAQUET. Have the VAVD CONTROLLER checked and repaired: if blood has been sucked from the reservoir into the VAVD CONTROLLER. Blood that has penetrated blocks the valves. if moisture or liquid has penetrated into the VAVD CONTROLLER. if delays occur when operating the vacuum controller. This may be caused by increased friction on the moving parts.
7.4
AUTHORIZED SERVICE For an inspection or repair, contact your responsible service point. This can be found on the MAQUET website (http://www.maquet.com) under “Service”. Select the country and device and click on “Click for local contacts”. Sending device to authorized service point If you send the device to an authorized service point, package the device so that it is protected from damage. If possible, use the original packaging or the packaging of a loaned or replacement device. Cover the connections on the back with caps before packing the device. VAVD CONTROLLER | User’s Manual | Multilingual | XX-07 Copyright MAQUET Cardiopulmonary AG
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| 7 Maintenance and authorized service | VAVD CONTROLLER |
| 16 | 8 Accessories | VAVD CONTROLLER |
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Sending device to authorized service point Remove all accessories and tubes. Only include the accessories necessary for inspection or repair. Enclose a description of the problem together with the name, address and telephone number of a contact person.
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ACCESSORIES Bracket 1/4" tubing set (red)
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TECHNICAL DATA Housing Dimensions (W x H x D)
183 x 100 x 200 mm
Weight
3.3 kg
Connections Vacuum source
1/4", rotatable
Venous reservoir
1/4", rotatable
Pressure gage
mechanical, Cl. 1.6, 0 to -120 mmHg
Vacuum control Possible settings
0 … -100 ±10 mmHg
Accuracy
at an air flow of +10 … -10 slpm: ±10 mmHg
Safety valves: Low pressure
opens at -100 ±10 mmHg
Overpressure
opens at 3 ±2 mmHg
Vacuum source requirements Vacuum
continuous vacuum -200 … -760 mmHg
Air flow
min. 11 slpm
Ambient conditions
Application
Storage and transport
Ambient temperature
10°C … 35°C
0°C … 60°C
Relative humidity (no condensation)
30% … 85%
10% … 96%
Air pressure
87 … 106 kPa
70 … 106 kPa
VAVD CONTROLLER | User’s Manual | Multilingual | XX-07 Copyright MAQUET Cardiopulmonary AG
For local contact: Please visit our website www.maquet.com
® MAQUET is a registered trademark of MAQUET GmbH & Co. KG · Order No. 70 103 59 06 · QUG:MCV-GA-10000707-XX-07 Copyright by MAQUET Cardiopulmonary AG, Rastatt · Subject to modifications due to technical development · 2012-06
MAQUET Cardiopulmonary AG Kehler Straße 31 76437 Rastatt GERMANY Phone: +49 7222 932-0 Fax: +49 7222 932-100 [email protected] www.maquet.com
GETINGE GROUP is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We operate under the three brands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh focuses on patient mobility and wound management solutions. GETINGE provides solutions for infection control within healthcare and contamination prevention within life sciences. MAQUET specializes in solutions, therapies and products for surgical interventions and intensive care.