DOUBLE MASK Before the Double mask may be taken into use, this manual must be studied carefully. Only, by MEDICVENT, authorized personnel are allowed to perform adjustments or repairs on this equipment. Only MEDICVENT original parts may be used in repairs. MEDICVENT reserves the right to perform changes, regarding construction and usage, without previous notice. REV: 2010-11-02/BS
Table of contents Safety 3 Intended use 4 Description 5 Components 6 Assembly 7 Instruction for use 7-9 Instruction for cleaning 9-10 Instruction for service 11 2
Safety Safety Double mask Only by Medicvent authorized personnel are allowed to perform adjustment or repairs on this equipment. Only MEDICVENT original parts may be used when repairing. Importance of safety symbols and headlines in use in this manual: It is of outermost important that instructions labelled with the symbol to the left is followed adequately Warning! Means risk for damages for patient and users N.B.! Means risk for damages on equipment. Use only MEDICVENT delivered and/or validated components. COMMENT Remark/reference. 3
Intended use The Double Mask intended use is to evacuate anaesthesia-gas that leaks out between patient and anaesthesia mask (escaping gas) so that personnel in the operation room will not be set for high concentrations anestesi-gas in the breathing air. Between patient and anaesthesia mask there is always gas leakages. This leakage gas is evacuated with a Medicvent Double mask. The leakage gas is evacuated out from the operation room with a Medicvent Fan system or a Medicvent Central system and out to the environment outside the hospital or to a purification apparatus where the gas is destroyed. 4
Description The Double mask is availably in 6 sizes and consists of a semi hard outer mask and a soft inner mask. The masks are transparent and the inner mask has edge that is softer than the inner mask to give an optimal fit to the patients face. Outer- and inner mask are from the factory connected together with a spreader. The Coupling house is attached to the Double mask by a cone with a sealing o- ring. The Coupling house has a connection port (ISO 22mm) for connection to anaesthesia breathing systems. The Coupling house connects to the flow meter with an Ø28 mm evacuation tube. A suction outlet connected to an evacuating system is mounted on a pendant or another convenient place in the operation room. The flow meter is connected to the suction outlet with an Ø40 mm evacuation tube. Anaesthesia gas is feed to the patient trough the coupling house to the mask, the gas spreads in the mask with a spreader plate witch is a part of the spreader. The leakage gas (escaping gas) that leaks out between the Double mask and the patient face is evacuated through the slot between the other and inner mask and evacuates trough the evacuating tube. Coupling house Outer mask Evacuating tube Spreader Inner mask 5
Components 10 9 11 2 1 5 4 3 8 6 7 Components: 1. 210000-5, Double mask 2. 210006, Coupling house 3. 220002, Evacuating tube Ø28x1900mm 4. 240000, Flow meter 5. 230005, Evacuating tube Ø40x2000mm 6. 238001, Ejector for exhausted gas 7. 238003, Flow indicator 8. 232005, Tube holder Other parts in picture: 9. 192014, Control panel 3- position 10. 532002, Suction outlet 11. Breathing system 6
Mounting Preparations The double mask parts are mounted together and is delivered hygienically packed. All parts must be cleaned before use. You find instructions on page 10-11 under section Cleaning-disinfection. Mounting (see illustration on page 7)) 1. Mount the flow meter with the arrow pointing up in suitable place, preferably on the anaesthetic apparatus side mounting rail. Try to route all tubes to be parallell. 2. Connect the Ø40 mm evacuating tube on the flow meter. If a Medicvent ejector is to be used mount it on the left side of the flow meter with the indicator hanging down and then mount the Ø40 mm tube on it. Connect the evacuating tube for exhausted gas to the indicator and to the anaesthesia apparatus. 3. Mount the Ø40 mm tube on the suction outlet. Instruction for use 4. Connect evacuating tube Ø28 mm between flow meter and Coupling house. 5. Make sure that the o-ring on the coupling house is lightly greased with silicon grease or equivalent. 6. Connect breathing tube between anaesthetic apparatus and the coupling house. 7. Make a leak and function test on the breathing system together with the coupling house. 8. Connect the Double mask to the coupling house. Choose suitably size of the Double mask and have some masks in different sizes ready for use. Flow adjustment with Central system: The suction flow is regulated when the knob on the control panel turns to L=low flow or H=high flow. The flow is adjusted with two adjustment potentiometers on the back of the panel. With the knob set at 0 there is no flow. 0-flow / fan is stopped Low flow, 27m³/tim High flow, 35m³/tim 1. Check the ball in the indicator glass on the flow meter for set flow. The upper mark indicates 35 m³/h= high flow. The lower mark indicates 27 m³/h= low flow. 2. Turn the knob on the control panel to L. With the potentiometer adjust the flow so that the ball in the indicator is in line with the lower mark. 3. Turn the knob on the control panel to H. With the potentiometer adjust the flow so that the ball in the indicator is in line with the upper mark. Medicvent 3-position panel, Article number 192014 7
Adjustment of flow with a fan system: The fan starts when the knob sets on L or H. It takes about 30 seconds before it reaches the set flow. The flow adjusts with the adjustment potentiometers on the back of the panel. 1. Set knob on L and wait about 30 seconds for the fan to start. 2. Adjust with the potentiometer so that the ball is in line with the lower mark on the flow meter. 3. Set the knob to H and adjust so the ball lined up to the upper mark. High flow, 35m³/tim Low flowadjustment High flowadjustment Low flow, Medicvent flow meter, Article number 240000 Use Choose a flow with the knob on the control panel. For a calm patient or a small Double mask L=Low flow is sufficient. Check the flow on the flow meter at every anaesthesia procedure. If flow meter not shows correct values there can be a leakage, then check tube connections or get technical help. Local scavenging A Coupling house can work as handhold close scavenging when the patient is waking up. The evacuating system can be used to evacuate vapours when filling anaesthetics in anaesthesia apparatus. If exhausted gas evacuator (ejector) is used Check the flow with indicator on ejector, the indicating float (red) should not be visibly in the indicators sight window, the anaesthesia apparatus must be turned on at this time. When the indicator float has lifted past the sight window there are at least 25 lit/min flow. 8
Important! Use a tube holder when this is possible. The tube holder helps to arrange the tubes so the mask can be position on the patient with little effort. Always try to balance the Double mask to be self positioned on the patient face. Hold the Double mask with lightly pressure on the patient face. Only use the fingertips (thumb and index finger) to hold the mask. The palm and the other finger are used to hold the patients chin to clear patient s airways. The mask can be removed from the patient face and be put aside without turning off the gas flow. The out flowing gas will be sucked up and evacuated trough the slot in the Double mask. Medicvent Tube holder, Article number 232005. *(Disinfication apparatus) Cleaning In the Swedish healthcare there are wash- and flushing disinfectors for heated disinfection. The disinfection temperature can be 70 o - 95 o C, witch in practice in Sweden means 90 o C. The disinfection process, time and temperature vary for different types of apparatus as by a conclusive type curve. For example shall the goods temperature reach at least 90 o C for 1 minute in a washing disinfector, an alternative can be 80 o C for 10 minutes or 70 o C for 100 minutes. Corresponding times for the goods temperature in flushing disinfectors are 80 o C for 1 minute or 70 o C for 10 minutes. *Inactivation with dry, saturated water steam. Sterilization with dry, saturated water steam with over pressure is the most environmentally friendly and most frequently used sterilization process in the healthcare. The effect is depending on that sufficient high temperature is achieved with sufficient time and how well the air is being replaced by water steam and the quality of that steam. In order to be certain that sterility is achieved 121 o C for 15 minutes or 134 o C for 3 minutes is recommended during the sterilization period on that part of the goods where the temperature is lowest. * Extracted and translated from the Swedish Vårdhandboken 2008-06-10. 9
Cleaning and disinfection All patients near parts, The Double mask, the Coupling house and the evacuating tube Ø28 mm can be cleaned in a autoclave in 120 C, or be washed up in an decontaminator without impact on the material. The flow meter and control panels just need wiping with disinfection solution. The cleaning process for the Double mask systems components can be divided in three groups: 1. Decontaminator (90 C) or autoclave (120 C): a. Masks (all parts) b. Coupling house (all parts) c. Tubes Ø 28 mm (made of Hytrel) d. All parts made of Hytrel 2. Washing in detergent solution specially intended for this type of products (60 70 C): a. Evacuating tube Ø 40 mm b. Soft 3. Wiping with disinfection solution: a. Flow meter b. Control panel c. Ejector Warning! All included parts are hygienically packed. All parts must be cleaned according to instructions before use. N.B! The double mask shall not be taken apart when cleaning. Cleaning Article no Component Material Cleaning 210000-5 Double mask, other mask Transparent Polysulfon Group 1 Inner mask Transparent Silicon Group 1 Spreader Hytrel Group 1 Clamp ring Stainless steel Group 1 210006 Coupling house, complete Transparent Polysulfon Group 1 220002 Evacuating tube Ø28 mm Hytrel Group 1 240000 Flow meter Aluminium, Acrylic Group 3 230005 Evacuating tube Ø40 mm Transparent POP Group 2 232001 Muff Ø38 mm PVC Group 2 230010 Evacuating tube Ø40 mm PVC, steel wire Group 2 192014 Control panel ABS+PC Group 3 250115 Control box PVC Group 3 232005 Tube holder PVC Group 3 238001 Ejector ABS, Acrylic, PVC Group 3 10
Service Flow meter Yearly cleaning, blowing all channels clean. And make a control of calibration. If the system is working accordingly with this manual and the designated flow meter, no other measures needs to be taken. Hytrel tubes Recommended use: No more than 24 month or 200 usages/cleanings. Keep in dark place when not in use, avoid sunlight. Always check for leakages before use. Reserve tubes shall always be on hand. Tubes that have turned yellow must be changed. Life endurance Medicvent recommends that the Double mask and the Coupling house are changed after 5 years of use. Because of aging, the materials changes in a way that the transparency decreases and the surface on masks and the Coupling house make it harder to clean and the risk of cracking increases. Storages time (before first use) Tubes of HYTREL can be stored 2 years in dark environment at room or lower temperature. Labelling The Coupling house, the Double masks inner mask and spreader are marked with 2 clocks each, the clocks shows production year and month. The pictures show the layout of the clocks. The inner masks can also be labelled with a LOT-marking according to SS EN 980:2008. Year Month Medicvent AB Pendelgatan 3 SE-904 22 Umeå 0413 Sweden 11
12 Medicvent AB Pendelgatan 3 SE-904 22 Umeå Sweden Phone: +46 90 12 75 00 Fax: +46 90 77 23 61 E-mail: info@medicvent.se www.medicvent.se