Related Manuals for Weinmann Emergency MEDUMAT Easy
Summary of Contents for Weinmann Emergency MEDUMAT Easy
- Page 1 MEDUMAT Easy Ventilator Aparato de respiración artificial Ventilador Description and instructions for use Descripción del aparato e instrucciones Descrição e instruções de funcionamento...
- Page 2 English Español Português...
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Page 3: Table Of Contents
Contents English Overview ....4 Hygienic preparation ..40 Device ..... 4 MEDUMAT Easy . -
Page 4: Overview
1. Overview 1.1 Device MEDUMAT Easy mbar Stenosis Disconnection < 2,7 bar O Demand- flow Freq.(min MV (l/min) Overview... - Page 5 Overview...
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Page 6: Special Symbols On The Ventilator
1.2 Special symbols on the ventilator Patient valve The symbol on the patient valve is a reminder that the lip membrane must be changed immediate- ly if it becomes crinkled, sticky or misshapen. The pa- tient must not be used again until the membrane has been changed, as this could cause malfunction (see “8.3 Checking patient hose system”... - Page 7 MEDUMAT Easy Inlet 2,7 - 6 bar O Languages available on this device MEDUMAT Easy device information plate Serial number of device Year of manufacture 3.6 V lithium battery Direct voltage CE symbol (confirms that the product conforms to the applicable European directives) Protection against ingress of water IP54...
- Page 8 Follow instructions for use Tube system connection Maximum pressure 100 mbar Safety check and servicing label Safety check label: (in Germany only) marks when the next safety check as per §6 of the German law relating to users of medical devices is required. Servicing label: indicates when the next service is due.
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Page 9: Legend
2. Legend A: MEDUMAT Easy control panel Mask/tube ventilation switch with indicator LEDs Ventilation pressure gauge Alarm panel Alarm mute button Colour code Regulator knob, ventilation parameters Stop notch LED Demandflow ON/OFF switch B: MEDUMAT Easy connections Pressurized gas connection Battery compartment Speaker Pressure gauge hose connection... -
Page 10: Description
3. Description 3.1 Intended use MEDUMAT Easy is an automatic oxygen respiration device (short-term ventilator) with additional inhala- tion facility. You can use MEDUMAT Easy: • to revive patients at the site of the emergency; • for longer periods in more protracted emergencies;... -
Page 11: Owner/Operator And User Qualification
(in Ger- many, the regulations governing owner/operators of medical devices apply in particular). Basic recom- mendation: get a person authorized by WEINMANN Emergency to provide you with proper instruction about the handling, use and operation of this medi- cal device. -
Page 12: Demandflow Function
fitted with a lip membrane that enables expired gas to be conducted away through the expiration tube. You can check the course of ventilation at ventilation mbar pressure gauge. 3.4 Demandflow function The Demandflow setting switches the Demandflow setting MEDUMAT Easy breathing-controlled O inhalation. -
Page 13: Audio Response
3.6 Audio response The device has an audio response facility that can be switched on for user guidance, especially for users who have little practice. If audio response is not required, a key combination can be used to switch it off (see “6.10 Audio re- sponse for user guidance”... -
Page 14: Safety Instructions
4. Safety instructions 4.1 Safety regulations For your own safety, the safety of your patients, and to comply with the requirements of EU Directive 93/ 42/EEC, please observe the following points: General • Please read the directions for use carefully. They are an integral part of the ventilator and must be kept available for reference at all times. - Page 15 MEDUMAT Easy” on page 64). • We recommend that maintenance work such as inspections and repairs be performed only by the manufacturer, WEINMANN Emergency, or by qualified technicians expressly authorized by WEINMANN Emergency. • Malfunctions and a lack of biocompatibility may result if third-party articles are used.
- Page 16 • Smoking and open flames are strictly prohibited in the vicinity of all fittings containing or trans- porting oxygen. • During assembly and when changing the oxygen cylinder, only hand pressure should be used when tightening the screw connections to the cylinder and to the pressure reducer.
- Page 17 Software • Extensive validation tests have been performed to minimize risks arising from software errors. Accessories • Please protect the silicone and rubber compo- nents from UV radiation and prolonged expo- sure to direct sunlight, as this can make them brittle and friable.
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Page 18: Installation
5. Installation A permanent mounting is usually necessary only when MEDUMAT Easy is installed as a fixture in res- cue vehicles, helicopters or aircraft. If MEDUMAT Easy is supplied complete on a porta- ble system or in an emergency rucksack, it is ready for use and requires no further installation. -
Page 19: Ventilation Hose
2. First switch off MEDUMAT Easy again. 3. Then loosen the screw connection to the cylinder. Connecting the new cylinder 1. First briefly open and close the valve of the new oxygen cylinder. This should blow out any particu- late matter. Keep the valve opening away from the body, making sure that neither yourself nor other per- sons can be injured by escaping particles. - Page 20 Always grasp the ventilation hose and pressure gauge tube by their end only, otherwise they may be damaged or split. 3. Connect the patient valve to the other end of the ventilation hose and pressure gauge tube. 4. If a mask is being used for ventilation, attach the mask connection to the patient valve (identical with tube connection), if the patient is intubated, attach the patient...
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Page 21: Wall Mounting Set
Note: Please note that the respiratory resistance of the entire system is increased when an HME filter or bac- teria filter is used and under certain circumstances, may exceed the value permitted by EN 794-3. PEEP valve If a PEEP valve is to be used, this should be inserted into the expiration tube on the patient valve. -
Page 22: Using The Ventilator
6. Using the ventilator 6.1 Switching on / self test 1. Open the valve of the oxygen cylinder slowly The pressure gauge will now show the pressure in the cylinder. 2. Where appropriate, calculate how long the re- maining oxygen will last (see “6.11 Calculation of oxygen content/remaining operating time”... -
Page 23: Selecting The Ventilation Settings
During this test, the four LEDs in alarm panel flash on and off and a short alarm tone sounds. Stenosis If an error is found, all the LEDs in alarm panel Disconnection < 2,7 bar O continue flashing and an alarm sounds. If this hap- pens, MEDUMAT Easy must not be used for venti- lation. - Page 24 The figures shown in the table are only recom- mendations. Different settings may be required in cases of pulmonary damage or for special indi- cations. To see the relationship between the values, see diagram “12.2 Relationship between ventilation parameters” on page 66. Maximum ventilation pressure 1.
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Page 25: Performing Ventilation
6.3 Performing ventilation Ventilation mask 1. Attach the mask to the patient valve. 2. If necessary, insert a Guedel tube to keep the airways open before putting on the mask. 3. Place the mask over the patient's mouth and nose. 4. -
Page 26: Ventilation With Peep Valve
the tidal volume set. Use suitable volume measuring devices to check the tidal volume actually adminis- tered. Check respiratory parameters during ventilation. If lung compliance diminishes during ventilation, the ventilator will react by increasing the ventilation pressure at constant volume. Example of ventilation sequence before and after lung compliance diminishes 6.5 Ventilation with PEEP valve... -
Page 27: Demandflow
inspiratory and expiratory resistance. You should therefore monitor ventilation pressure and ventila- tion volume very carefully. A close watch must be kept for any increase in dead space, especially in children. Always be sure to follow the instructions supplied by the manufacturer of the filter. -
Page 28: Terminating Ventilation Or Demandflow
position marked by the white triangle, or by switch- ing off the ventilator. If audio response is activated, the ventilator confirms the return to ventilation mode by announcing: “Mask ventilation mode. Tilt back head, secure mask tightly” (from serial number 8000 and following re- pair/servicing/firmware update: “Ventilation pres- sure limit 20 mbar”). -
Page 29: Alarm Signals
6.9 Alarm signals Alarm panel signals the following alarms: Stenosis Disconnection Stenosis: Stenosis, or maximum ventilation < 2,7 bar O pressure P reached in two succes- sive inspiration phases Disconnection:Disconnection between MEDUMAT Easy and patient in two successive inspiration phases <... - Page 30 Simultaneous disconnection and drop in oxygen pressure will initially set off only the < 2.7 bar alarm. Stenosis alarm Actual ventilation pressure exceeds the maximum ventilation pressure (20 or 45 mbar). MEDUMAT Easy briefly switches to expiration if the maximum ventilation pressure is exceeded, but then tries to continue inspiration in the same inspiration phase.
- Page 31 Disconnection alarm in Demandflow mode If the patient does not trigger MEDUMAT Easy with- in 15 seconds, the “Disconnection” alarm is given. If audio response is enabled, the unit announces “Rule out respiratory arrest and check mask fit”. < 2.7 bar O alarm Oxygen pressure at the pressure connection to the MEDUMAT Easy has dropped to less than 2.7 bar.
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Page 32: Audio Response For User Guidance
Stenosis: 30 seconds Disconnection: 30 seconds < 2.7 bar: 30 seconds 120 seconds + – Even if audio response is enabled, no messages will be output for the periods stated. The visual alarm will continue to flash. If the cause of the alarm is not eliminated, the acous- tic alarm will start to sound again after a short inter- val. - Page 33 Language, Level 2 Device number mbar Language, Level 1 (Stenosis and disconnection alarm LEDs come on) Icelandic Finnish Norwegian Swedish Danish WM 28000 Portuguese Still free WM 28100 (French variant) Spanish WM 28050 Dutch (French variant) Italian French English German Brazilian Portuguese Audio response off Audio response off...
- Page 34 3. Press mask/tube switch as many times as neces- sary until the LED for the desired language lights up and a corresponding message is heard (exam- ple: LED 10 mbar, language: English, message: “Selected language: English”). After five seconds the new selection is stored. Tip: By pressing the ON/OFF switch briefly you can store the language selection without waiting for...
- Page 35 Table 1: Audio response up to Meaning serial number 7999 “Open oxygen cylinder” Open oxygen cylinder valve slowly Depending on whether or not the patient is breathing, set “Check respiration and MEDUMAT Easy to one of the modes Demandflow (Page 27), mask select mode”...
- Page 36 Table 2: Audio response from serial number 8000 and following repair/ Meaning servicing/firmware update “Open oxygen cylinder” Open oxygen cylinder valve slowly Depending on patient weight, set respiration frequency and minute “Adjust settings and connect volume (Page 23). Connect patient to ventilator via ventilation hose patient!”...
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Page 37: Calculation Of Oxygen Content/ Remaining Operating Time
6.11 Calculation of oxygen content/remaining op- erating time Oxygen content of cylinder Oxygen volume = volume of cylinder x cylinder pressure. Cylinder volume x cylinder pressure = oxygen content Example 1 10 l x 200 bar = 2000 l Example 2 10 l x 100 bar = 1000 l... - Page 38 Real Demandflow time Example: Max. flow Inhalation flow 45 l/min BV = 1,5 l BV = 1,5 l Patient data: Inspiration : Expiration (I : E) = 1 : 2 I = 2 sec E = 4 sec I = 2 sec Respiratory frequency = 10 min = 0.033 min = 0.066 min...
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Page 39: Alternative Ventilation Procedures
1. Remove the patient valve from the tube or the mask. 2. Replace it with the ventilation bag, e.g. a WEINMANN Emergency COMBIBAG WM 11000, and perform manual ventilation. Exhaustion of oxygen supply In emergency situations when the oxygen supply runs out, MEDUMAT Easy can also be operated with respiratory air. -
Page 40: Hygienic Preparation
7. Hygienic preparation the MEDUMAT Easy and any acces- After every use sories used must undergo hygienic preparation. • Be sure to carry out a functional check after ev- ery hygienic preparation (see “8. Functional checks” on page 45). • Dis- This product may contain disposable items. - Page 41 2. Dismantle the patient valve as shown in the ad- jacent diagram. It is neither necessary nor per- missible to remove the membrane in the spontaneous breathing tube for cleaning and disinfection. membrane Disc mem- Disc membrane brane Spontaneous Expiration tube breathing tube 3.
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Page 42: Ventilation Hose
7.3 Ventilation hose Caution! Only reusable hose system WM 22520 (scope of supply) is suitable for the hygienic preparation de- scribed here. Do subject disposable hose system WM 28110 available as an accessory to hygiene preparation. Replace it with a new one. 1. -
Page 43: Cleaning And Disinfection Procedure
Never immerse the fittings in disinfectants or other liquids. You may only disinfect them by wiping. On no account may liquid get into the pressure reducer, as this could cause explosions. 7.6 Cleaning and disinfection procedure Hygienic preparation of the MEDUMAT Easy and the accessories used should be performed as described in the following table. - Page 44 1. Connect one end of the pressure gauge tube to a sterile disposable 20-ml syringe. 2. Immerse the other end in the dilute disinfectant ® solution (for gigasept FF (new): residence time 15 minutes). 3. Draw the disinfectant solution through the pres- sure gauge tube into the syringe until the latter is full.
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Page 45: Functional Checks
First try to correct the error with the help of the in- formation provided in section “9. Troubleshooting” on page 54. If this is not possible, have the unit re- paired by the manufacturer – WEINMANN Emergency – or by specialists explicitly authorized by WEINMANN Emergency. -
Page 46: Intervals
• lip membranes for the patient valve. Note: Ensure that the test bag is not damaged and test its function regularly, e.g. in the context of device servicing. 8.1 Intervals Before each use: • Perform a functional check. After each use or dismantling: •... -
Page 47: Checking For Leaks In The System
8.2 Checking for leaks in the system 1. Open the valve of the oxygen cylinder slowly You can now read the pressure in the cylinder from the gauge on the pressure reducer. For ex- ample, a reading of 200 bar means that the cyl- inder is full, whereas 100 bar means it is half full. -
Page 48: Check Patient Hose System
8.3 Checking patient hose system Checking reusable hose system 1. Dismantle the patient valve. 2. Carry out a visual check of all components for cracks or other physical damage. The lip membrane must be replaced if it is crin- kled, sticky or misshapen. It must no longer be used for ventilation as it could cause serious functional problems. -
Page 49: Checking The Minute Volume
• the hose connections must be located firmly and securely on the connecting pieces. • the patient valve and emergency air membranes may not exhibit any damage or deformation. 8.4 Checking the minute volume Checking ventilation frequency 1. Open the valve of the oxygen cylinder slowly 2. -
Page 50: Checking Maximum Ventilation Pressure
ensures a breath volume of 1 litre per inspiration stroke. At all events the test bag is not sufficient- ly inflated if a disconnection alarm is set off. Note: During the expiration phase, you must simulate the expiration stroke of the test bag by hand. To do so, place the test bag on a firm base. -
Page 51: Checking Demandflow
MEDUMAT Easy must set off the alarm. stenosis Usually this occurs after the second inspiration stroke. 5. Switch the mask/tube switch to 6. Repeat the check for intubation ventilation with the settings: – MV: 9 l/min / frequency: 10 min –... -
Page 52: Checking The Alarm Systems
6. The MEDUMAT Easy switches the flow on and then immediately off again. This test can be re- peated several times. 7. Switch off MEDUMAT Easy again. 8.7 Checking the alarm systems Stenosis Important In the case of the stenosis 1. - Page 53 After two successive inspiration phases the dis- alarm should be set off. If audio re- connection sponse is enabled, the ventilator announces “Check ventilation system and settings”. Drop in O pressure (<2.7 bar O 1. Open the valve of the oxygen cylinder slowly 2.
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Page 54: Troubleshooting
9. Troubleshooting Fault Cause Remedy MEDUMAT Easy defective. Arrange for repair. Replace battery in battery compartment (10.1, page 57). MEDUMAT Easy will not If ventilator still refuses to switch on, switch on. Battery failing. have internal auxiliary battery replaced by manufacturer or authorized specialists. - Page 55 Fault Cause Remedy Visual alarms flashing, but no acoustic alarm and no audio response. Acoustic alarm, but no Short-term electronic problem or visual alarm flashing. defect in electronic system. Switch off, then on again. If error recurs, arrange for repairs. Acoustic alarm sounds and all visual alarms flashing.
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Page 56: Servicing
10. Servicing Have the cleaned and disinfected device serviced at regular intervals. Servicing, safety checks ([sicher- heitstechnische Kontrollen or STKs] in accordance with §6 of the German law governing the owners/ operators of medical devices - only applies to Germa- ny) and maintenance measures such as servicing and repairs may only be performed by the manufacturer or by specialists expressly so authorized by the man-... -
Page 57: Batteries
The batteries are completely replaced every two years during servicing. We recommend having the batteries changed only by the manufacturer – WEINMANN Emergency – or by qualified specialists expressly authorized by the manufacturer. Special precautions need to be taken during the change in order to protect the electronic system. -
Page 58: Change Valve Membrane In Patient Valve
Use only batteries supplied by WEINMANN Emergency. 10.2 Change valve membrane in patient valve If one of the valve membranes in the expiration or spontaneous breathing arms of the patient valve is crinkled, sticky or misshapen, it must be changed. -
Page 59: Disposal
Disposing of batteries/rechargeable batteries Used batteries/rechargeable batteries may not be disposed of in domestic waste. Contact WEINMANN Emergency or your local authority waste disposal de- partment. Disposing of the patient hose system After use, the patient hose system should be dis- posed of properly with plastics. -
Page 60: Product And Accessories
11. Product and accessories 11.1 Standard product MEDUMAT Easy, complete 28000 comprising: – MEDUMAT Easy, single unit 28010 – Operating instructions 16862 – Summary of operating instructions 16844 – Set of mounting attachments 15007 – Ventilation hose and patient valve with spontaneous breathing facility (reusable) 22520 –... - Page 61 11. Disposable ventilation mask – size 3, for children and juveniles 10563 – size 5, for adults 10565 12. Set tracheal tubes (disposable): – Set tracheal tubes 15075 – Set tracheal tubes, DIN 13232-N 15076 – Set tracheal tubes, DIN 13232-K 15077 13.
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Page 62: Spare Parts
11.3 Spare parts 1. Washer for pressure hose WM 1145/31 2. Set of mounting attachments 15007 3. Battery, Li 3.6 V 28045 4. Ventilation hose and patient valve with spontaneous breathing facility (reusable) 22520 comprising: – respiration tube, twin lumen 22647 –... -
Page 63: Technical Data
Patient valve 15 mm socket according to from the manufacturer – inspiration tube 22 mm plug EN 60601-1-2 (WEINMANN Emergency – mask/endotracheal ISO 5356-1 and EN 794-3: Medical Technology tube GmbH + Co. KG, Patient valve 30 mm socket Frohboesestraße 12,... - Page 64 MEDUMAT Easy MEDUMAT Easy Patient valve 12,8 ml (reusable) Alarm sound 60 dB (A) dead space 8 ml (disposable) pressure Materials used for Pressure gauge ±5% of upper range PC, silicone, PVC, PP, PS, disposable hose sys- accuracy value ® EVA, K-Resin Patient valve Components with...
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Page 65: Pneumatic / Electronic Systems
12.1 Pneumatic / electronic systems Function Relief valve 3/2-way valve Pneumatic system 100mbar Patient valve Ventilation Pressure regulator RF/MV hose 2,7-6bar 2,5 bar Exp. Flow Booster valve with Pressure Coupling element metering facility gauge tube Insp. Respiratory frequency Position Electronic Demandflow system Stenosis... -
Page 66: Relationship Between Ventilation
Demandflow An inspiration impulse (trigger) at V2 opens valves V3 and V4. Electronic system The microprocessor-controlled electronic system sets the ventilation parameters and monitors ventilation, and also O supply and power supply. If necessary, a visual and acoustic alarm is given. The ventilator has an audio response facility that can be switched on for user guidance. -
Page 67: Warranty
13. Warranty WEINMANN Emergency gives the customer a limited manufacturer warranty on new original WEINMANN Emergency products and any replacement part fitted by WEINMANN Emergency in accordance with the warranty conditions applicable to the product in question and in accordance with the warranty periods from date of purchase as listed below. -
Page 68: Index
15. Index accessories..........60 alternative ventilation procedures ..39 audio response general...........13 messages ........34 settings ..........32 batteries ..........57 cleaning..........40 demandflow checking ........51 general...........12 settings ..........27 switching off ........28 disposal ..........59 Filter .............20 functional checks........45 intubation..........25 operating time........37 patient valve checking ........48 cleaning .........40 general...........12 PEEP valve..........21 safety instructions.........14... - Page 70 WEINMANN Emergency Medical Technology GmbH + Co. KG Frohboesestraße 12 22525 Hamburg GERMANY E: customerservice@weinmann-emt.de www.weinmann-emergency.de T: +49 40 88 18 96-120 F: +49 40 88 18 96-481 Center for Production, Logistics, Service WEINMANN Emergency Medical Technology GmbH + Co. KG...