VENTI-O 2 plus. O 2 switching valve for: VENTImotion from serial number 4000 VENTIlogic from serial number 4000 VENTImotion 2

Transcription

1 VENTI-O 2 plus O 2 switching valve for: VENTImotion from serial number 4000 VENTIlogic from serial number 4000 VENTImotion 2 Device description and operating instructions

2 Overview VENTI-O 2 plus with therapy device 2 Therapy device 3 Tube system 1 VENTI-O 2 plus 4 Test bellows VENTI-O 2 plus 6 Status indicator 7 O 2 inlet 5 O 2 outlet 8 Plug-in contact 9 Locking pins 2 Overview

3 Legend 1 VENTI-O 2 plus VENTI-O 2 plus is an O 2 switching valve. Using VENTI-O 2 plus, up to 15 l/min oxygen can be delivered to the respiratory air by the therapy device during ventilation. 2 Therapy device VENTI-O 2 plus can be used with the following therapy devices: VENTImotion from serial no.: 4000 VENTIlogic from serial no.: 4000 VENTImotion 2 3 Tube system The respiratory air enriched with oxygen flows through the tube system into the mask. 4 Test bellows The test bellows are used to perform the functional check on the VENTI-O 2 plus. 5 O 2 outlet Oxygen flows out of the O 2 outlet into the therapy device, where the oxygen is mixed with the respiratory air. 6 Status indicator Used for the functional check of the VENTI-O 2 plus. The status indicator comes on when the VENTI-O 2 plus delivers oxygen to the therapy device. 7 O 2 inlet For connecting an oxygen system (concentrator, liquid oxygen system, oxygen cylinder with pressure reducer, central gas supply system with pressure reducer). 8 Plug-in contact For supplying energy to and controlling the VENTI-O 2 plus. 9 Locking pins For positioning the VENTI-O 2 plus securely on the casing of the therapy device. Overview 3

4 Markings on the device VENTI-O 2 plus 1 2 Rating plate Symbol VENTI-O 2 plus 1 2 O 2 inlet O 2 outlet Significance Rating plate Symbol Significance Do not dispose of the device with domestic waste Year of manufacture Degree of protection against electric shock: device Type B Oxygen supply, max. 15 l / min O 2 Type of protection against electric shock: device of protection class II 4 Markings on the device

5 Markings on the pack Symbol Significance Permitted storage temperature: - 40 C to + 70 C Permitted humidity for storage: max. 95% relative humidity Protect pack from wet Do not drop pack or let it fall Safety information in these instructions Safety information in these operating instructions is marked as follows: Warning! Warns of risk of injury and potential material damage. Caution! Warns of material damage and potentially false therapy results. Note Contains useful tips. Markings on the pack 5

6 Contents 1. Description of the device Intended use Description of function Safety information Safety instructions Setting up the device Connecting to a therapy device Connecting to an oxygen system Using humidifiers Operation Switching on the device Switching off the device Hygienic preparation Intervals Cleaning/disinfecting Change of patient Functional check Intervals Performing the check Troubleshooting Servicing Intervals Disposal Product and accessories Standard product Spare parts Technical data Specifications Pneumatic plan Warranty Declaration of Conformity Index Contents

7 1. Description of the device 1.1 Intended use VENTI-O 2 plus can be used with following Weinmann devices: VENTImotion from serial number 4000 VENTIlogic from serial number 4000 VENTImotion 2 The VENTI-O 2 plus can be used to deliver up to 15 l/min oxygen (O 2 ) into respiratory air during ventilation. The VENTI-O 2 plus can be used in combination with an oxygen concentrator, an oxygen cylinder with pressure reducer, a continuous-flow liquid oxygen system or a central gas supply system with pressure reducer. The oxygen system must have its own flow control device. Warning! The VENTI-O 2 plus may only be used for patients who are not at risk from an undetected failure of the oxygen supply as the VENTI-O 2 plus - like the therapy device - does not have an alarm to indicate oxygen delivery faults. Only use the device for the purpose described here. 1.2 Description of function The VENTI-O 2 plus is clicked onto the side of the therapy device. It is controlled and supplied with energy by the therapy device. If the therapy device and the oxygen system are switched on and working properly, the VENTI-O 2 plus automatically starts delivering oxygen. The green status indicator of the VENTI-O 2 plus comes on. If the therapy device is switched off or if a fault (e.g. power failure) occurs, the VENTI-O 2 plus stops delivering oxygen to the therapy device. The green status indicator of the VENTI-O 2 plus goes out. Description of the device 7

8 2. Safety information 2.1 Safety instructions Read these operating instructions carefully. They are an integral part of the device and must be available at all times. Only use the device for the purpose described (see 1.1 Intended use on page 7). For your own safety and the safety of your patients and in accordance with the requirements of Directive 93/42/EEC, please note the following points. Oxygen delivery Warning! Smoking and naked flame are prohibited during delivery of oxygen into the respiratory flow. Risk of fire. Oxygen can accumulate in clothing, carpets, bedding or hair. Ventilate thoroughly after use to reduce the accumulation of oxygen. Keep all parts free of oil and grease. Hydrocarbon compounds such as oils, greases, cleaning alcohols, hand cream and adhesive plasters can lead to explosive reactions in combination with oxygen. If a fault occurs, the VENTI-O 2 plus stops delivering oxygen. It is therefore essential in the event of a fault that you shut off your oxygen system to ensure that the tube connection between the oxygen system and the VENTI-O 2 plus does not come loose. If the tube connection should have come loose, shut off your oxygen system. Ventilate the room thoroughly after use to reduce the accumulation of oxygen. The amount delivered must be set using a flow control device (not included in the scope of supply). The flow rate may not exceed 15 l/min for this. Higher delivery rates can lead to accumulation of oxygen in the therapy device. Risk of fire. Never operate the VENTI-O 2 plus in a bag. Oxygen may accumulate in the bag. Risk of fire. Caution! Oxygen therapy can have adverse effects if used/dosed incorrectly. For this reason you must only use the device as prescribed by a doctor. Make sure that it always delivers the flow rate prescribed by the doctor. 8 Safety information

9 Always follow the safety information in the operating instructions for your oxygen system! Use only oxygen systems with a maximum static pressure not exceeding 1000 hpa. At higher static pressures, a tube connection in the oxygen supply system may come loose. Make sure that all components used are designed for the static pressure of your oxygen system, otherwise there is a risk of damage to your device. Operating the device Caution! Only use the device for the purpose described (see 1. Description of the device on page 7). To prevent infection or bacterial contamination, observe section 5. Hygienic preparation on page 13. Do not allow liquids to enter the therapy device or the casing of the VENTI-O 2 plus. This could damage the electronic system. Do not use any antistatic or electrically conductive tubes. Maintain a safe distance between the therapy device and equipment which emits HF radiation (e.g. cell phones). The device may otherwise malfunction (see operating instructions for the therapy device). Accessories/Spare parts/repairs Caution! Malfunctions and bioincompatibility may result if third-party articles are used. Please note that in such cases, all warranty entitlement and liability claims shall be void where items other than the accessories or original spare parts recommended in the operating instructions are used. Have repairs carried out only by the manufacturer - Weinmann - or consult your specialist dealer. Safety information 9

10 3. Setting up the device 3.1 Connecting to a therapy device 1. Set up your therapy device as described in the relevant operating instructions. Then assemble the VENTI-O 2 plus as follows. 2. Clip the VENTI-O 2 plus onto the side of the therapy device. Ensure that it engages fully. 3.2 Connecting to an oxygen system To connect to the oxygen system, you need an oxygen tube with an internal diameter of 4 mm. To ensure proper functioning of the VENTI-O 2 plus, the tube should be no longer than 20 m. Connecting to an oxygen concentrator 1. Set up your oxygen concentrator as described in the relevant operating instructions. Do not switch on the concentrator yet. 2. Fit the oxygen tube of your concentrator onto the O 2 inlet of the VENTI-O 2 plus. Connecting to an oxygen cylinder with pressure reducer 1. Set up your oxygen cylinder with pressure reducer as described in the relevant operating instructions. Do not open the cylinder valve yet. 2. Fit the oxygen tube of your cylinder system to the O 2 inlet of the VENTI-O 2 plus. 10 Setting up the device

11 Connecting to a continuous-flow liquid oxygen system Connecting to a central gas supply system 1. Set up your liquid oxygen system as described in the relevant operating instructions. Leave the flow control in position Fit the oxygen tube of your liquid oxygen system to the O 2 inlet of the VENTI-O 2 plus. 1. Insert the flow control with pressure reducer into the appropriate wall socket. Do not open the flow control yet. 2. Connect the flow control and the O 2 inlet of the VENTI-O 2 plus to the oxygen tube. 3.3 Using humidifiers You can use the VENTIclick humidifier to humidify respiratory air. Alternatively, an HME filter can be used close to the patient. Additional humidification of the oxygen using bubble or sterile water humidifiers is permitted, but not necessary. A humidifier needs to be protected from excessive pressure. On humidifiers with an excess pressure valve, it should be ensured that no oxygen escapes at the excess pressure valve during operation, otherwise too little oxygen is mixed into the respiratory air. Follow the operating instructions for your humidifier. The use of nebulizers is not permitted. Caution Make sure that the bubble/sterile water humidifier used is designed for the maximum static pressure of your oxygen system. Follow the operating instructions for the VENTIclick and for the bubble humidifier, otherwise there is a risk of damage to your device. Setting up the device 11

12 4. Operation 4.1 Switching on the device VENTI-O 2 plus is ready for operation once the device has been connected as described in 3. Setting up the device on page 10. To start therapy, first switch on your therapy device and then your oxygen system (at the prescribed flow rate, max. 15 l/min). The VENTI-O 2 plus automatically enables oxygen delivery. The green status indicator comes on. There is no further need to control the device during operation. 4.2 Switching off the device Please observe the following sequence when switching off the devices. 1. Switch off the O 2 supply on your oxygen system; depending on the system: switch off oxygen concentrator, close cylinder valve (cylinder oxygen), close flow control (liquid oxygen) or disconnect therapy device from the central gas supply system. 2. Switch off your therapy device. This also switches off the VENTI-O 2 plus. The green status indicator goes out. 12 Operation

13 5. Hygienic preparation 5.1 Intervals The casing should be wiped down regularly. 5.2 Cleaning/disinfecting Cleaning the casing 1. Detach the tube from the VENTI-O 2 plus. 2. Detach the VENTI-O 2 plus from the therapy device. 3. Wipe the casing, the plug-in contact, the locking pins and the O 2 inlet with a soft damp cloth. The plug-in contact and the O 2 inlet must be completely dry before you start up the device. Disinfecting the casing Clean the casing, the plug-in contact, the locking pins, the O 2 inlet, the O 2 outlet and the connecting line to the O 2 system simply by wiping with disinfectant. We recommend TERRALIN for this purpose. We recommend that you wear suitable gloves (e.g. household or disposable gloves) for disinfecting. Refer to the operating instructions for the disinfectant used. Sterilizing Sterilizing is not permitted. 5.3 Change of patient If there is a change of patient, replace the tube system and clean the outside of the VENTI-O 2 plus by wiping with disinfectant. Hygienic preparation 13

14 6. Functional check 6.1 Intervals Perform a functional check every day. 6.2 Performing the check Use the following test to see whether the valve of the VENTI-O 2 plus is opening and closing correctly. Proceed as follows for the test. Connect the VENTI-O 2 plus to the therapy device. Do not switch on the therapy device. The status indicator on top of the VENTI-O 2 plus does not come on. 1. Slip the opening of the test bellows over the O 2 inlet of the VENTI-O 2 plus. 2. Squeeze the test bellows. The device is working correctly if you are unable to force air through the valve. The test bellows can only be squeezed with difficulty. You feel considerable resistance. The test bellows remain firm and retain their round shape. 3. Plug the drying adapter onto the outlet of the therapy device. 4. Switch on your therapy device. The therapy device starts working. The status display of the VENTI-O 2 plus comes on and the valve opens with a soft click. 14 Functional check

15 5. Squeeze the test bellows. The device is working correctly if you are able to force air through the valve. The test bellows are easy to squeeze. The test bellows remain in the squeezed position. 6. Switch off your therapy device. The test bellows remain squeezed. Take the test bellows off the O 2 inlet of the VENTI-O 2 plus. If your VENTI-O 2 plus does not work as described above, please contact your specialist dealer or the manufacturer - Weinmann - to have the device repaired. Functional check 15

16 7. Troubleshooting Fault Cause Remedy Status indicator does not No power supply come on or comes on only from time to time, although the therapy Leak in breathing mask device is working properly. Check plug-in contact for firm fit Adjust cap so that mask is a firm fit. If necessary, replace faulty mask. Flow rate does not reach prescribed level. O 2 supply tubes kinked Outlet pressure of oxygen system not high enough Check tube connections. If necessary use a different oxygen system (e.g. OXYMAT 3). Passage in therapy device blocked Please contact your specialist dealer. Warning! If there are faults which cannot be eliminated immediately, switch off the device and the oxygen supply and do not use any more. Otherwise there is a risk of fire. Contact the manufacturer - Weinmann - or your specialist dealer to have the device repaired. 16 Troubleshooting

17 8. Servicing 8.1 Intervals The VENTI-O 2 plus requires no servicing. 9. Disposal Disposal Do not dispose of the device as domestic waste. To dispose of the valve properly, contact a licensed, certified electronic scrap recovery firm. You can find out their address from your environment officer or from your municipal authorities. Servicing 17

18 10. Product and accessories 10.1 Standard product Oxygen switching valve VENTI-O 2 pluswm Description of component Order no. Oxygen switching valve VENTI-O 2 plus, basic device WM Test bellows WM Operating instructions VENTI-O 2 plus WM Spare parts Description of component Order no. Test bellows WM Operating instructions VENTI-O 2 plus WM Product and accessories

19 11. Technical data 11.1 Specifications VENTI-O 2 plus Product class under 93/42/EEC II a Dimensions W x H x D in cm 8.0 x 9.3 x 3.0 Weight approx. 190 g Temperature range Operation Storage Air pressure range Pneumatic connection Inlet Outlet Permitted humidity for operation and storage Electrical connection Current consumption during operation Classification to EN Type of protection against electric shock - Degree of protection against electric shock Electromagnetic compatibility (EMC) to EN Radio interference suppression Radio interference immunity +5 C to +35 C 40 C to +70 C hpa only tubes with 4 mm internal Ø O 2 outlet into therapy device 95 % rh (no condensation) 12 V DC 135 ma Class II Type B EN EN to 3 EN Max. permitted flow rate 15 l/min. O 2 Min. required O 2 supply pressure at valve inlet for 4 l/min O 2 for 15 l/min O 2 Max. permitted static pressure of pressure source Permitted therapy pressures 100 hpa 300 hpa 1000 hpa 4 to 35 hpa (1 hpa = 1 mbar 1 cm H 2 O) We reserve the right to make design changes. Technical data 19

20 11.2 Pneumatic plan VENTI-O 2 plus External oxygen supply Control by therapy device Delivery of O 2 to the therapy device 20 Technical data

21 12. Warranty Weinmann offers a warranty that the product, when used in accordance with requirements, will remain free from defects for a period of two years from date of purchase. For products whose durability is clearly indicated as less than two years, the warranty expires on the expiration date indicated on the packaging or in the user s manual. Claims against the warranty can be made only when accompanied by the sales receipt, which must show salesperson and date of purchase. We offer no warranty in the case of: Disregard of usage instructions Operating errors Improper use or improper handling Third-party intervention by non-authorized persons for the purpose of device repair Acts of God, e.g., lightning strikes, etc. Transport damage as a result of improper packaging of returned items Lack of maintenance Operational and normal wear and tear, which includes, for example, the following components. Filter Batteries / recheargable batteries Articles for one-time usage, etc. Failure to use original spare parts. Weinmann is not liable for consequential harm caused by a defect if it is not based on intention or gross negligence. Weinmann is also not liable for minor physical injury to life or limb resulting from negligence. Weinmann reserves the right to decide whether to eliminate defects, to deliver a defectfree item or to reduce the purchase price by a reasonable amount. If Weinmann rejects a claim against the warranty, it assumes no expense for transport between customer and manufacturer. Implied warranty claims remain unaffected by these changes. Warranty 21

22 13. Declaration of Conformity Weinmann Geräte für Medizin GmbH + Co. KG declares herewith that the product complies fully with the respective regulations of the Medical Device Directive 93/42/EEC. The unabridged text of the Declaration of Conformity can be found on our website at 22 Declaration of Conformity

23 14. Index C Change of patient 13 Cleaning 13 D Disinfecting 13 F Functional check 14 O Overview 2 P Pneumatic plan 20 S Safety instructions 8 Servicing 17 Spare parts 9, 18 T Technical data 19 Troubleshooting 16 W Warranty 21 Index 23

24 Weinmann Geräte für Medizin GmbH + Co. KG P.O. Box D Hamburg Kronsaalsweg 40 D Hamburg T: +49-(0) F: +49-(0) E: info@weinmann.de Center for Production, Logistics, Service Weinmann Geräte für Medizin GmbH + Co. KG Siebenstücken 14 D Henstedt-Ulzburg WM 66831b 12/2012 EN