OMNIVAC secretion aspiration system Description of device and instructions for use

Transcription

1 OMNIVAC OMNIVAC secretion aspiration system Description of device and instructions for use

2 Contents 1.Description of device Intended use Description of function Safety instructions Assembly Operation Starting work Aspiration Regulate aspiration of secretions Stop aspiration Hygiene treatment Preparation Method Reassembly Function checks Intervals Visual inspection Determine available oxygen quantity Check the suction performance of manual aspiration Check the suction performance of the screw-on injector Check the suction performance of other vacuum sources Troubleshooting Servicing Intervals Disposal Scope of supply Standard scope of supply Accessories Replacement parts Technical data Warranty Declaration of conformity

3 WM13731 Nicht für Patienten intubierende max min Overview 4 Connector for connecting tube 3 Connection to vacuum source 2 Ball for overflow cutout 1 Bracket for 500 ml and 1000 ml aspirate bottles 11 Swivel bracket for 250 ml aspirate bottle 19 Screw-on injector 7 Connector for connecting tube 8 Filling limit 9 Tensioning strap 10 Aspirate bottle 13 Connecting tube 5 Connector for aspirating tube 6 Aspirate bottle lid 12 Vacuum tube 22 Pressure reducer 20 Nonreturn valve 21 Connection for vacuum tube 14 Aspirating tube, largelumen ø 10 mm 15 Connector, aspirating tube 16 Aspirating tube ø 6 mm 17 Aspirating catheter 18 End-piece with fingertip regulator 18 End-piece with fingertip regulator 19 Screw-on injector 16 Aspirating tube ø 6 mm 12 Vacuum tube 15 Connector, aspirating tube 14 Aspirating tube, largelumen ø 10 mm 6 Aspirate bottle lid 10 Aspirate bottle 23 Pony trolley

4 1. Description of device 1.1 Intended use 1.2 Description of function You can use OMNIVAC to remove secretions such as mucus and blood, as well as liquid, viscous and solid pieces of food from your patient's oral cavity, naso-pharynx and bronchial system, thus obviating the need for aspiration. OMNIVAC can be connected to a variety of vacuum sources. OMNIVAC can be used on a mobile basis or in a fixed position. The vacuum source connected to connection 3 generates a vacuum in the system. This results in air, fluids and solid components being aspirated into the aspirate bottle 10 by aspirating tube 14. An overflow cutout is integrated in lid 6. This prevents secretions penetrating the connected vacuum source by ball 2 floating on the surface of the secretion and blocking the outlet. If two aspirate bottles are connected, the overflow cutout is only in the bottle closer to the vacuum source. 2 EN Description of device

5 2. Safety instructions For your own safety and that of your patients, and in accordance with the requirements of directive 93/42/EEC, observe the points below. General Please read these instructions for use through carefully. They are a constituent part of the device and must be available at all times. Use the OMNIVAC for the described purpose only (see 1.1 Intended use on page 2). The vacuum source may not exceed bar. OMNIVAC should be used only if you are medically qualified and have received training in aspiration techniques. Physical damage may be caused by incorrect use. Have servicing and repair work performed only by the manufacturer, Weinmann, or by professional staff. If third-party items are used, functional failures may occur and fitness for use may be restricted. Biocompatibility requirements may also not be met. Please note that in such cases, any claim under warranty and liability will be voided if neither the accessories nor genuine replacement parts recommended in the instructions for use are used. We recommend keeping an alternative aspiration option, e.g. the MANUVAC manual aspiration pump, to hand in case of device failure. Protect rubber parts from UV light and prolonged exposure to direct sunlight, otherwise they may become brittle and friable. To prevent infection or bacterial contamination, please observe section "5. Hygiene treatment" on page 11. Safety instructions EN 3

6 Oxygen Spontaneous explosive reactions can occur if highly-compressed oxygen comes into contact with flammable substances (grease, oil, alcohol etc.). Keep the devices and all screwed connections absolutely free of oil and grease. Always wash your hands before starting to work on the oxygen supply. Smoking and naked flames are strictly prohibited in the vicinity of fittings containing or transporting oxygen. During assembly and when changing cylinders, tighten all screwed connections on the oxygen supply and on the pressure reducer only by hand. Never use tools for this purpose. Excessive tightening damages the screw threads and seals and then causes leaks. Secure oxygen cylinders against falls. If a cylinder falls onto the pressure reducer or the valve, these may break off, causing a violent explosion. Important Always open the cylinder valve slowly to stop pressure hammer to the fittings. Do not empty cylinders completely, otherwise damp ambient air may penetrate and lead to corrosion. Aspiration During the aspiration process, take particular care that no injuries are caused to the patient's mouth and pharynx (the mucous membranes, for example) when aspirating. You can interrupt suction briefly by opening the fingertip regulator. For bronchial aspiration, work under sterile conditions and use only sterile aspirating catheters. 4 EN Safety instructions

7 Important! Dispose of fluids such as blood and secretions, together with any parts contaminated by them, in accordance with national hygiene guidelines. Ensure that the aspirate bottles are always upright during aspiration, otherwise the ball of the overflow cutout cannot reliably block the outlet. 3. Assembly Assembling the brackets Weinmann usually installs these on portable systems, in emergency cases or on the trolley. The following brackets are obtainable separately (see 9.2 Accessories on page 21). Aspirate bracket for 250 ml WM 2246 Aspirate bracket, swivel, for 250 ml WM 2262 Aspirate bracket for carrypack WM 2236 Aspirate bracket 1 x 500 ml, 1 x 1000 ml WM 2298 To fit the bracket, screw it to a suitable place. For third-party vacuum generators, the following is defined: max. vacuum 0.8 bar max. flow rate 20 l/min Vacuum sources We recommend the following Weinmann devices as vacuum generators: screw-on injector WM 2286 Suction Module WM 22220, WM Combi Module WM 22210, WM Install screw-on injector 1. Screw the pressure-reducer onto the gas cylinder. 2. Connect screw-on injector 19 to the distributor strip. Assembly EN 5

8 3. Connect the distributor strip to the pressure reducer. Insert aspirate bottle 1. Put aspirate bottles 10 in the bracket (e.g. bracket 1 or swivel bracket 11). 2. If necessary, fix the aspirate bottles to the bracket with tensioning straps 9. Insert bacteria filter We recommend fitting a hydrophobic bacteria filter WM for the exhaust air to prevent secretion and bacteria penetrating the screw-on injector. Filter WM is obtainable as an accessory, individually or in sets. It is a disposable item and must be replaced after every aspiration operation. 1. Take the vacuum tube off the screw-on injector. 2. Cut a piece about 6 cm long off the vacuum tube. 3. Put this short piece of tube onto the side of the filter marked TO PUMP. 4. Put the other end of the short piece of tube onto the vacuum connection of the screw-on injector. 5. Put the free end of the vacuum tube on the filter. 6 EN Assembly

9 Install aspirate bottle and tube connections 1. Connect vacuum tube 12 to the vacuum source. 2. Connect vacuum tube 12 to tube connector 3 in aspirate bottle lid 6. Important! When two aspirate bottles 10 are used, please note that the bottle with overflow cutout 2 is connected to the vacuum source first. 3. Connect the aspirate bottles together using connecting tube 13 at connectors 4 and 7. The arrows on the lid show the direction of flow. 4. Large-lumen aspirating tube 14 is connected to connector 5 for aspiration. The standard aspirating tube consists of large-lumen aspirating tube (ø 10 mm) 14 and aspirating tube (ø 6 mm) 16 with fingertip regulator 18. A third-party catheter is defined as follows: sterilized catheters with a tube diameter of 2.0 to 4.0 mm 5. Aspirating catheter 17 can be pushed straight onto fingertip regulator 18. Assembly EN 7

10 4. Operation 4.1 Starting work Tip Cleaning will be facilitated if you pour about 50 ml of disinfectant or water into the aspirate bottles before you start. The aspirated matter is then less likely to adhere to the bottom of the bottle. Fingertip regulator Catheter 1. If necessary, adapt the end-piece of an aspirating catheter of a suitable size for tracheal or nasopharyngeal aspiration. Aspirating tube End-piece Important! For effective aspiration of viscous and solid pieces of food from the oral cavity, take the end-piece off the aspirating tube and use the aspirating tube on its own. 2. Switch on the vacuum source. If you have installed a screw-on injector, for example, open the gas cylinder slowly. When using the screwon injector, ensure that the oxygen cylinder (see 6.3 Determine available oxygen quantity on page 14) is sufficiently full. 3. Set the vacuum using the stop valve on the distributor strip maximum vacuum will then apply. 8 EN Operation

11 4.2 Aspiration Pay attention during the aspiration process to ensure that no injuries are caused to the patient's mouth and pharynx, especially to the mucous membranes. You can briefly interrupt suction, for example if the skin is aspirated, by opening fingertip regulator 18. You can leave the fingertip regulator permanently open and hold it closed with a thumb. You then only need to lift your thumb briefly for venting. Important! Please ensure that aspirate bottles 10 are always upright during operation, otherwise ball 2 of the overflow cutout cannot reliably block the connection to the vacuum source. This could result in secretion getting into the vacuum source. The aspirate bottle can also be removed from the bracket to allow aspiration to be performed using the large-lumen tube. Note Keep an eye on the fill level of the aspirate bottle during aspiration. Always empty the aspirate bottle as soon as fill limit 8 is reached. This will prevent the overflow cutout becoming contaminated and minimize cleaning effort. If two aspirate bottles are connected, the secretion is aspirated into the front bottle first. When this aspirate bottle is full, it overflows into the second one. Empty aspirate bottle When the aspirate bottle is full to filling limit 8, you must interrupt the aspiration process and empty the aspirate bottle. Operation EN 9

12 The exact procedure for cleaning is described in Section "5. Hygiene treatment" on page Regulate aspiration of secretions Min. Max. 1. Seal fingertip regulator 18 and set the vacuum using the regulator spindle. Pressure is displayed on the pressure gauge. 4.4 Stop aspiration When the aspiration process is complete, proceed as follows. 1. Switch off the vacuum source. 2. Empty and clean the OMNIVAC (see 5. Hygiene treatment on page 11). Transport OMNIVAC Before transporting OMNIVAC, you should empty aspirate bottle 10. This will prevent the contents spilling or leaking out somewhere. 10 EN Operation

13 5. Hygiene treatment This product may contain disposable items. Disposable items are intended to be used only once. So use these items only once and do not reprocess them. Reprocessing disposable items may impair the functionality and safety of the product and lead to unforeseeable reactions as a result of ageing, embrittlement, wear, thermal load, the effects of chemical processes, etc. The OMNIVAC and the accessories used must be subjected to a hygiene treatment after every use. After that, you should always perform a function check (see 6. Function checks on page 14). 5.1 Preparation Note When taking off and emptying aspirate bottles, ensure that the lid does not accidentally come off an aspirate bottle and cause the contents to spill. 1. Take the tubes off the aspirate bottles and the vacuum source. 2. Take connector 15 and fingertip regulator 18 out of the aspirating tube. Note The end-piece with fingertip regulator 18 is a disposable item and should be disposed of after use. 3. If appropriate release the tensioning strap of the bracket and take aspirate bottle 10 out of the bracket. 4. Take off aspirate bottle lid Empty the aspirate bottle. Hygiene treatment EN 11

14 Comply with the relevant regulations on disposal (see 2. Safety instructions on page 3). 6. Take the connectors out of the aspirate bottle lids. 7. Take ball 2 out of the overflow cutout. To do so, pull the rubber flaps apart so that the ball can drop out. 8. On an OMNIVAC with regulating device, take off the regulating device. 9. Wash all parts in clean hot water. You can use a mild domestic detergent for this. Warning! The regulating device may not be kept submerged in the water. 5.2 Method The individual parts can be cleaned, disinfected and sterilized as listed in the table below. Follow the instructions for use for the disinfectant used. We recommend GIGASEPT FF. It is recommended that suitable gloves (e.g. household or disposable gloves) are used for disinfecting. Parts Cleaning Disinfecting Washing machine cycle Sterilizing Aspirate bottles Aspirating tube Intermediate tube Vacuum tube Aspirate bottle lid Ball of overflow cutout Connectors End-piece with fingertip regulator In hot water with a mild household detergent Immerse in dilute solution (1) Washing cycle up to 95 C Not permitted Disposable item, re-use not permitted, replace for every patient Hot-steam sterilization up to 134 C (2) 12 EN Hygiene treatment

15 Parts Cleaning Disinfecting Bacteria filter Washing machine cycle Disposable item, reuse not permitted Sterilizing (1) After disinfecting the parts, rinse them thoroughly in distilled water and then leave them to dry. 2) Hot steam sterilization at 134 ºC in devices to EN 285, dwell time 5 minutes. 5.3 Reassembly Following the hygiene treatment, reassemble the parts as described in "3. Assembly" on page 5. Hygiene treatment EN 13

16 6. Function checks If you detect faults or deviations from specified values in the course of your final testing, you may not use OMNIVAC again until these faults have been remedied. We recommend that you always keep in stock: aspirating tube, 10/15 mm ø, 280 mm long WM 2201 aspirating tube, 6/10 mm ø, 800 mm long WM 2203 aspirating tube, 10/15 mm ø, 230 mm long WM connecting tube 13, ø 4/9 mm WM 2207 seal for screw-on injector WM 1145/ Intervals Perform a function check before using the OMNIVAC each time. Perform a function check at least every 6 months if the device has not been used. 6.2 Visual inspection 1. Check that all parts are in perfect condition. Damaged, torn or brittle parts must be replaced. 2. Check that tube connections, the lid and the vacuum source connection are tight. 6.3 Determine available oxygen quantity 1. Open the oxygen supply valve slowly. You can now read off cylinder pressure at the pressure gauge of the 14 EN Function checks

17 pressure reducer. A display of 200 bar, for example, means that the cylinder is full, whilst at 100 bar, it is still half full. You should ensure that you have a refill or reserve cylinder ready to guarantee the operational readiness of the device for example, if the pressure gauge displays 50 bar or less. Calculating filling level Oxygen volume = cylinder volume x cylinder pressure. Cylinder volume x cylinder pressure = oxygen reserve Example 1 10 l x 200 bar = 2,000 l Example 2 2 l x 100 bar = 200 l Calculating operating time for aspiration Example O 2 reserve = 1000 l; consumption for aspiration 15 l/min (max.): Operating time for aspiration (min) = 1,000 l 15 l/min = 66.7 min 6.4 Check the suction performance of manual aspiration 1. Hold end-piece 18 in boiled or sterilized water. 2. Squeeze the aspirating ball firmly three times. 3. Hold up the aspirating tube by end-piece 18 so that the water flows out of the aspirating tube into aspirate bottle 10. If your aspirate bottle now contains at least 100 ml of water, suction performance is fine. Function checks EN 15

18 6.5 Check the suction performance of the screw-on injector -0,6-0,4-0,8-0,2 bar -1,0 O Connect the Weinmann test pressure gauge to fingertip regulator Switch on the screw-on injector. 3. Read off the value on the test pressure gauge. After no more than 30 seconds, at least -0.5 bar must be displayed. If this value is not reached, the connections must be checked for leaks. Replace leaking tubes if necessary. Ensure that the aspirate bottle lid is correctly located. Replace the seal on the screw-on injector if necessary. 6.6 Check the suction performance of other vacuum sources In the case of other vacuum sources, see the relevant information in the associated instructions for use. 16 EN Function checks

19 7. Troubleshooting Fault Cause of fault Remedy Unusually high oxygen consumption Leak in system Find and eliminate leak Overflow cutout responds before the filling limit is reached Inadequate vacuum or none at all Aspirate bottle is tilted Bacteria filter blocked (due to penetration by moisture, for example) Vacuum source defective Leak in system Blockage in system Oxygen cylinder of screw-on injector is empty Briefly interrupt the aspiration process. Switch off the vacuum source. Keep the aspirate bottle upright (with its lid uppermost) and wait until the ball drops back down. Change filter; if necessary, take out and complete aspiration without filter Have vacuum source repaired Eliminate leak Eliminate blockage Connect a full oxygen cylinder 8. Servicing 8.1 Intervals OMNIVAC requires no servicing. We recommend having servicing and repairs carried out by the manufacturer, Weinmann, or by qualified staff. Troubleshooting EN 17

20 8.2 Disposal Do not dispose of the unit with domestic waste. For proper disposal of the device and its components, please contact a certified waste disposal site. Ask your Environmental Officer or local council for the address. Appliance packaging (cardboard and inserts) may be disposed of in the paper recycling bin. 18 EN Servicing

21 9. Scope of supply 9.1 Standard scope of supply Article Order number Secretion aspiration device WM 2260 Secretion aspiration device WM 2285 Secretion aspiration device WM 2275 Secretion aspiration device WM 2250 Secretion aspiration device WM 2265 Aspirate bottle, 250 ml WM off Aspirate bottle, 500 ml WM off Lid with overflow cutout WM 2182 Lid WM 2254 Aspirating tube WM 2204 Vacuum tube WM 2207 Connecting tube WM 2207 Connecting piece NW4, 6/13 WM 4638 End-piece with fingertip regulator WM 2251 Screw-on injector WM 2286 Instructions for use WM Secretion aspiration device WM 2280 Scope of supply EN 19

22 Article Order number Secretion aspiration system, regulatable, 1000 ml WM 2206 Secretion aspiration system, regulatable, 500 ml WM 2205 All parts can be re-ordered individually Secretion aspiration device with injector and ml aspirate bottle WM 2135 Manual secretion aspiration pump Aspirate bottle, 250 ml WM 2272 Aspirate bottle, 500 ml WM 2273 Aspirate bottle, 1000 ml WM 2271 Lid with overflow cutout WM 2182 Lid with regulating device WM 2631 Aspirating tube WM 2204 Vacuum tube WM 2207 Connecting piece NW4, 6/13 WM 4638 End-piece with fingertip regulator WM 2251 Screw-on injector WM 2286 Aspiration ball with valves WM 2270 Cap for pressure gauge WM Instructions for use WM WM EN Scope of supply

23 9.2 Accessories Aspirate bracket for 250 ml WM 2246 Aspirate bracket, swivel, for 250 ml WM 2262 Aspirate bracket for carrypack WM 2236 Aspirate bracket 1 x 500 ml or 1x 1000 ml WM 2298 Aspirate bracket for Pony trolley, complete WM 2190 (only supplied assembled) Aspirating catheter WM 5156 Aspirating catheter WM 5157 Aspirating catheter WM 5158 Set of bacteria filters, 1x WM Set of bacteria filters, 10x WM Set of bacteria filters, 50x WM End-piece with fingertip regulator WM 2251 Test pressure gauge set for vacuum WM Scope of supply EN 21

24 9.3 Replacement parts Aspirate bottle lid, complete WM 2182 Aspirating tube, silicone, 10/15 mm ø, 280 mm long WM 2201 Aspirating tube, silicone, 6/10 mm ø, 800 mm long WM 2203 Aspirating nozzle with fingertip regulator and plug WM 2251 Elbow tube connector WM 2252 Aspirate bottle lid WM 2254 Connecting piece WM 2261 Aspirate bottle, polysulfone, 1000 ml WM 2271 Aspirate bottle, polysulfone, 250 ml WM 2272 Aspirate bottle, polysulfone, 500 ml WM 2273 Screw-on injector WM 2286 Aspirating nozzle WM 2289 Aspirate bottle lid with regulating device WM 2631 Injector lid with regulating valve and vacuum meter WM 2665 Aspirating tube, silicone, 10/15 mm ø, 230 mm long WM Tensioning strap WM 8776 Seal for screw-on injector WM 1145/31 Ball for overflow cutout WM EN Scope of supply

25 10. Technical data OMNIVAC 1 x 250 ml OMNIVAC 2 x 250 ml OMNIVAC 1 x 500 ml OMNIVAC 1 x 500 ml regulatable OMNIVAC 2 x 500 ml OMNIVAC 1 x 1000 ml OMNIVAC 1 x 1000 ml regulatable Width Height Depth 130 Weight 0.68 kg 0.9 kg 0.74 kg 0.89 kg 1.05 kg 0.88 kg 1.00 kg Aspirating tube Diameter 10/15 x 280 mm and diameter 6/10 x 1500 mm Temperatur e range Max. permitted vacuum Max. permitted suction performance Product category according to 93/42/ EEC Operating temperature: -18 C to +50 C Storage temperature: -40 C to +60 C bar 20 l/min IIa Screw-on injector Vacuum Consumption Suction performance bar 13 l/min +2 l 9 l/min ±10 % Subject to technical change without notice. Technical data EN 23

26 11. 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 and 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 defect-free 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. 24 EN Warranty

27 12. 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 Declaration of conformity EN 25

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30 Weinmann Geräte für Medizin GmbH+Co.KG P.O.Box D Hamburg Kronsaalsweg 40 D Hamburg T: +49-(0) F: +49-(0) E: Center for Production, Logistics, Service Weinmann Geräte für Medizin GmbH+Co.KG Siebenstücken 14 D Henstedt-Ulzburg WM16232a