Instructions for use COMBIBAG
Contents
1. Spare parts 15 21 Spare parts 7 Technical and performance data COMBIBAG Classification acc to EC directive 93 42 EEC lla Dimensions L x D 340 mm x 130 mm inflated Weight 390 g Scope of use Child grip 10 16 kg body weight adult grip gt 16 kg body weight Pressure relief optionally 20 mbar and 60 mbar Resistance of inspiration 2 17 mbar at 50 I min Resistance of expiration 2 23 mbar at 50 I min Patient access 15 mm tapered connecting socket and 22 mm tapered plug according to ISO 5356 Expiration branch 30 mm tapered plug according to ISO 5356 Junction for oxygen intake nozzle 6 mm Dead space 5 ml Forward leak 0 05 Temperature range Storage 40 C to 70 C Operation 18 C to 50 C Materials Valves polysulphone Squeeze bag compressable silicone unit valve diaphragms Technical and performance data Tidal volumes and respiratory frequencies cycles per minute The follwing frequencies and tidal volumes are ob tained during ventilation with COMBIBAG Cycles per min Tidal volume in ml Child grip 2 fingers 150 3 fingers 60 150 200 4 fingers 200 300 hand 300 500 Adult grip 1 hand gt 25 500 950 2 hands 1200 Inspiratory Oxygen concentration The oxygen concentration achievable during ven2. finger or by gentle tapping e Rapidly squeeze the bag several times to blow out any foreign particles e Screw in the valve cage check the function and continue ventilation Note Always check the function of the resuscitator after cleaning and re assembly e Partially cover the patient connection e Squeeze the bag and check the valve element for correct function and leak ightness see 4 2 Check ing the function on page 10 5 2 Maintenance and service With proper use and maintenance of the COMBIBAG no additional service is required Just the intake dia phragm should be examined once a year The dia phragm is ready for proper use if no cracking spots are visible Wavy distorted or sticked items have to be replaced A frequent functional check is recommended to be car ried out according to Pt 4 2 Checking the function 16 Hygienic preparation 6 Spare parts 6 1 Standard scope of supply Item no Description of component Order no COMBIBAG resuscitation bag for adults and WM 11090 children without face masks COMBIBAG resuscitation bag for adults and WM 11020 children with 1 face mask consisting of COMBIBAG resuscitation bag WM 11000 22 ventilation mask with inflatable silicone cushion WM 5074 for adults Size 5 COMBIBAG operating instructions WM 16009 COMBIBAG resuscitation bag for adults and WM 11025 children with 2 masks consisting of COMBIBAG resusci
3. all by two longitudinal troughs marked with appropriate symbols The tidal volume required can be obtained by squeezing the adult or child segment e up to 500 ml in child ventilation e 500 1200 ml in adult ventilation The usual separate child bag becomes unnecessary The princiole of two bags in one is extremely eco p p g Y nomical and saves space in each emergency kit COMBIBAG the first manual resuscitator with a 2 stage safety valve By now pressure relief as a function of the variable risks present in ventilation via face mask or endotrache al tube remained unsolved The majority of manual resuscitators only have a pres sure limit at 50 60 mbar 50 60 cm H2O a rea sonable limit adapted to healthy lung conditions With use of manual resuscitators and face mask venti lation in inexperienced hands however there is al ways the risk that anxiety of the administrator and the eager trial to produce very effective ventilation may lead to an inflation of the stomach at pressures above Basic principle 5 20 mbar resulting in regurgitation with following api ration Moreover there is the risk with ventilation of children independant from face mask or endotracheal tube that high ventilation pressures may hurt the lungs With the COMBIBAG 2 stage safety valve it is now possible to set a pressure limit O f 20 mbar 20 cm H O for mask res
4. elief valve Squeeze bag Intake port inner part with diaphragm Intake port cover with holding ring COMBIBAG should undergo hygienic purification af ter every use Upon completion of the purification process carry out a functional test ndividual parts of the COMBIBAG resuscitator are made of silicon or polysufone Use soapy water to dean COMBIBAG and rinse under running water For cleaning purposes take apart the bag separating the pieces into components as de scribed Warning When assembling or disassembling COMBIBAG do not use any sharp edged objects The patient valve does not have to be dismantled in order to be cleaned Should you choose to dismantle the valve anyway do not unscrew the cap of the valve since that could change the pressure setting of the valve To disinfect the equipment use a disinfectant that is suit able for rubber and polysulfone Be sure to observe the instructions for the disinfectant We recommend GIGASEPT FF Sterilization with steam hot air or gas should be car ried out according to standard practices after careful cleaning of the individual parts The oxygen reservoir cannot be sterilized It should be cleaned and disinfected Hygienic preparation 15 5 1 Cleaning during use Should the valve become blocked as a result of regur gitation clean it as follows e Unscrew the valve cage e Clean the valve element and valve body with the
5. emergency COMBIBAG Resuscitator WM 11000 Description and Operating Instructions WEINM ANN medical echnology Overview COMBIBAG Patient valve Safety valve Squeeze bag compressable unit Intake valve Accessories PEEP valve DEMAND valve IE Contents 1 Basic principle eee eee eee eee 4 lu APUDO S us a an eRe EG 4 1 2 FUNGON a d ee ae 4 1 3 Special Features of the COMBIBAG 5 2 Description of the resuscitator 7 2 1 COMBIBAG components 7 3 Safety instructions cc 9 4 Operating instructions 10 4 1 Introductory remarks 2222222222222 O 4 2 Checking the function O 3 Guide values for ventilation 1 4 4 Mask ventilation 2o 22 222 200 2 4 5 Ventilation via an endotracheal tube 2 6 Increasing the oxygen concentration 3 4 7 PEEP ventilation 4 4 8 Volume measurement 4 4 9 Use of HMEFilters occisus 4 5 Hygienic preparation lesse 15 5 1 Cleaning during use aoaaa ee 6 5 2 Maintenance and service 6 6 Spare parts 2er eee vias IRR ext 17 6 1 Standard scope of supply 7 6 2 Accessories cei 8 6 3 Spare PAS eea i ao lesen 9 7 Technical and performance data 22 8 Warranty erar Piri ao dae os 24 9 Decla
6. esuscitation bag should be proven before each use and can be checked in a ew seconds as follows e Squeeze the bag with the right hand and cover the patient valve with the left hand regardless of the re lief valve setting air can be felt and heard to flow into the left hand Release the bag it expands rapidly and air can be heard to f ow through the inlet valve 10 Operating instructions e Relief valve setting 20 mbar 20 cm H O on clos a r e Relief valve setting 60 mbar 60 c ing the inhalation passage with the ball of the left thumb and squeezing the bag with the right hand ir flows through the relief valve openings m H O on clos ing the inhalation passage with the ball of the left thumb the bag can only be squeezed under con siderable pressure and air escapes more slowly and quietly than at the 20 mbar pressure setting 4 3 Guide values for ventilation When carrying out artificial ventilation with resuscita tors without adjustable frequency and tidal volume un less additional measuring instruments such as pressure T3 gauges or volumeters are employed success of the procedure can only be judged from indirect signs such as clearly visible cyanosis reducti horax movements disappearance of ion in pallor etc Because of this cer tain guide values should be noted after commencing re s
7. for WEINMANIN COMBIBAG DEMAND resuscitation bags Item no Description of component Order no Spiracle demand valve with pressure tube 1 500 mm G 3 8 connection WM 22127 Spiracle demand valve with pressure tube 1 500 mm sealing nipple Walther type Rz Spiracle demand valve with pressure tube 1 500 mm DIN 13260 connector WM 22129 Ventilation mask transparent with inflatable silicone cushion 22 Adult size 5 WM 5074 23 Children and young people Size 3 WM 5082 24 Babies and small children Size 1 WM 5086 18 Spare parts Item no Description of component Order no Ventilation mask all in one silicone Size 5 WM 5084 Size A WM 5085 Size 3 WM 5083 Size 2 WM 5092 Size WM 509 Size O WM 5090 Rendell Baker ventilation mask silicone 21 Children Size 3 WM 5063 20 Children Size 2 WM 5062 19 Small children Size 1 WM 5061 18 Babies Size O WM 5060 Set of Rendell Baker ventilation masks silicone consisting of ventilation mask each 21 for children from 3 12 years WM 5063 20 for children from 1 3 years WM 5062 WM 15482 19 for small children up to one year old WM 5061 18 for infants WM 5060 Set of oropharyngeal tubes Guedel type consisting of 1 tube each for adults Size 3 for young people Size 2 WM 15483 for children Size 1 for small children Size O for infants Size OOO See illustration o
8. ial contamination please observe section 5 Hygienic preparation on page 15 Warning The uni be used in a toxi e The unit is only a personell trained ed with the instru e In operation with Hakes in ambient air so it may not c atmosphere lowed to be used by experienced in resuscitation and well acquaint ment oxygen it is imperative that smok ing and open fire around the oxygen fittings is strict ly prohibited e Oil and grease should not be used in conjunction with the resuscitation unit e Not for infants and children with a body weight below 10 kg e More copies of this operating instructions are avail able from the manufacturer WEINMANN Safety instructions 9 4 Operating instructions 4 1 Introductory remarks Although it is commonly assumed that resuscitation should be carried out only after respiratory failure has been confirmed it must be emphasized that it should be commenced as soon as symptoms such as cyanosis and or e visibly reduced respiratory movements and or very low respiratory frequency and or e diminished respiratory murmur and or e diminished air flow indicate dangerous suppression or restriction of spon taneous brea thing This ensures that all forms of hy poventilation such as dead space breathing and breath rattlin 4 2 Checking the function u g are covered The function of the COMBIBAG r
9. improper packaging of returned items lack of maintenance Operational and normal wear and tear which inclu des for example the following components Filter Batteries and recheargable batteries Articles for one time usage etc failure to use original spare parts e 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 e WEINMANN reserves the right to decide whether to liminate defects to deliver a defectfree item or to redu ce the purchase price by a reasonable amount e IF WEINMANN rejects a claim against the warranty it assumes no expense for transport between customer and manufacturer e Implied warranty claims remain unaffected by these changes 24 Warranty 9 Declaration of conformity WEINMANN Ger te f r Medizin GmbH Co KG declares herewith that the product complies fully with the respective regulations of the Medical Device Direc tive 93 42 EEC The unabridged text of the Declara tion of Conformity can be found on our website at www weinmann de Declaration of conformity 25 Weinmann Ger te f r Medizin GmbH Co KG P O Box 540268 D 22502 Hamburg Kronsaalsweg 40 e D 22525 Hamburg T 49 0 40 5 47 02 0 F 49 0 40 5 47 02 461 E info weinmann de www weinmann de Center for Prod
10. m H O in excep tional cases only where adequate ventilation still cannot be achieved However inflation of the stom ach is not then excluded and must be considered 4 5 Ventilation via an endotracheal tube To prevent additional complications overinflation of the stomach with consequent aspiration ventilation via a correctly placed endotracheal tube is to be aimed at wherever possible 12 Operating instructions e Intubation e Press the red ring on the COMBIBAG relief valve downwards pressure limit 60 mbar cm H O e Even with ventilation via an endotrachel tube one should aim for a pressure limit of 20 mbar cm H O in order to limit the drop in the heart circulation time caused by increase in resistance in the pulmonary circulation 4 6 Increasing the oxygen concentration In emergency situations oxygen concentrations above that in the ambient air 21 vol or even 100 oxy gen may be indicated since oxygen deficiency often has to be reckoned with at the first supply phase Any oxygen concentration can be administered with the COMBIBAG resuscitator Oxygen concentrations up to 48 can be administered directly via the oxygen socket on the intake connection If a higher concentra tion of oxygen is to be administered an oxygen reser voir or a demand valve can be used Connect corrugated hose e Fit the oxygen reservoir into the cone on the intake socket and e push the oxygen con
11. n page 21 6 3 Spare parts For COMBIBAG Item no Description of component Order no COMBIBAG resuscitation bag for adults and WM 11000 children Cord ring 42 mm old suspension ring WM 1145 43 1 Suspension ring new 60 mm WM 1145 49 Spare parts 19 Item no Description of component Order no Seal 30 35 x 0 5 mm WM 1145 82 5 Bellows WM 11001 Valve housing WM 11002 6 12 Ventilation valve without safety valve WM 11003 Guide stub WM 11004 Valve element WM 11006 Valve insert WM 11007 4 Inlet membrane WM 11008 2 Intake stub inner part WM 11021 3 Intake stub outer part WM 11022 13 2 stage safety valve WM 11030 6 13 _ Ventilation valve complete WM 11035 Disk spring WM 11043 Intake stub with inlet membrane WM 11051 Adapter for OXYMAND demand valve 17 mm WM 22169 internal diameter 24 mm external diameter Lockring 30 x 1 5 mm WM 50455 See illustration on page 21 For ventilation masks Description of component Order no Mask binding ring or WM 5074 and WM 5082 ul Sealing plug or WM 5074 WM 5082 WM 5086 elle nflatable silicone mask cushion or WM 5074 WM 11086 nflatable silicone mask cushion or WM 5082 aller nflatable silicone mask cushion or WM 5086 WM 11088 Mask body for WM 5074 WM 11097 Mask body for WM 5082 WM 11098 Mask body for WM 5086 WM 11099 20
12. necting tube onto the connec tor at the end of the corrugated hose Connect demand valve e Attach demand valve with appropriate adapter WM 22169 e Follow the instructions for use for the demand valve Operating instructions 13 4 7 PEEP ventilation Many disturbances in lung function disturbances in distribution exudation atelectasis etc can be pre vented or their effects reduced by application of a Positive End Expiratory Pressure PEEP A PEEP valve can be fitted directly to the exhalation passage of the patient valve 4 8 Volume measurement To prevent hypo or hyperventilation in the case of pro longed manual resuscitation with the COMBIBAG a volumeter for measuring the expired gas volume can be connected to the expiration branch of the patient valve 4 9 Use of HME Filters For hygienical reasons and for climatizing the breath ing air the inspiratory branch of the patient valve can be fitted with commercial 15 22 mm standard cone HME ilters heat and moisture exchanger This insig nificantly increases the inspiratory as well as the expi ratory resistance The extend of the death space volume has to be considered particularly with children Observe the operating instructions of the manufacturer and chapter 3 Safety instructions on page 9 14 Operating instructions 5 Hygienic preparation Valve cage with expiration cone Patient valve a Safety valve r
13. of the resuscitator 7 Squeeze bag The squeeze bag compressable unit is divided into segments by two asymmetrical troughs marked with pictograms symbol of a child and of an adult and creates the gas volume required on squeezing the cor responding segment Intake valve The intake valve con e valve intake port e intake port cover e valve plate to al ing a seal when sists of inner part with connecting socket or oxygen enrichment ow the inlet of fresh gas and form the bag is squeezed e silicone ring for hanging up the COMBIBAG 8 Description of the resuscitator 3 Safety instructions 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 e Carefully observe the operating instructions which is part of the inst the time rument and must be available all e The detailed knowledge and attention of this oper ating instructions are the basis for proper use of the COMBIBAG The instrument is just determined for the field of use stated e Malfunctions and a lack of biocompatibility may re sult if third party ar icles are used Please bear in mind that in these cases any warranty entitlement and liability shall lapse where the accessories rec ommended in the instructions for use or original spare parts are no utilised e To prevent infection or bacter
14. ration of conformity 25 l Basic principle 1 1 Purpose The COMBIBAG is for the manual ventilation of chil dren from a body weight of 10 kg and adults via a face mask or endotracheal tube The respiratory oir can be enriched with oxygen 1 2 Function On squeezing the bag a volume of gas air air en riched with oxygen or pure oxygen is forced through the resuscitation valve into the patient s lungs As soon as the elastic bag is released it fills up again via the inlet valve resuming its former shape At the same time the diaphragm in the patient valve closes the connection to the bag and opens the expiration passage The patient then exhales into the atmosphere and expired air cannot flow back into the bag In case of spontaneous breathing the patient can breathe in dependanily in and out via the expiration passage k Exspiration Intake valve Bag filling up Compression Patient valve non rebreathing valve 4 Basic principle 1 3 Special Features of the COMBIBAG COMBIBAG the first manual resuscitator m segmental division for adults and chil ren Hitherto at least 2 resuscitation bags were required to ventilate patients of all age groups a child resuscita tion bag and a large adult resuscitation bag ow the special design featuring the COMBIBAG covers both functions The bag is divided into two seg ments one large and one sm
15. tation bag WM 11000 22 ventilation mask with inflatable silicone cushion WM 5074 for adults Size 5 23 ventilation mask with inflatable silicone cushion WM 5082 for children and young people Size 3 COMBIBAG operating instructions WM 16009 COMBIBAG resuscitation bag for adults and WM 11026 children with 2 face masks consisting of COMBIBAG resuscitation bag WM 11000 silicone ventilation mask for adults Size 5 WM 5084 silicone ventilation mask for young people WM 5083 Size 3 COMBIBAG operating instructions WM 16009 Spare paris 17 6 2 Accessories Item no Description of component Order no COMBIBAG resuscitation bag for adults and WM 11050 children with 3 face masks consisting of COMBIBAG resuscitation bag WM 11000 22 ventilation mask with inflatable silicone cushion WM 5074 for adults Size 5 23 ventilation mask with inflatable silicone cushion WM 5082 for children and young people Size 3 24 ventilation mask with inflatable silicone cushion WM 5086 for babies Size 1 COMBIBAG operating instructions WM 16009 See illustration on page 21 Item no Description of component Order no PEEP valve with tapered connector infinitely adjustable from O 10 mbar 22 mm external WM 3215 diameter 14 17 Oxygen reservoir for COMBIBAG WM 11052 See illustration on page 21 The following combination units with adapter are available
16. tila tion depends on the oxygen flow set the minute vol ume and the respiratory frequency The follwing oxygen concentrations are achieved depending upon the type of oxygen supply direct supply or oxygen sup ply with reservoir Flow Adults Children ganze Hand 3 Finger without with without with without with reservoir reservoir reservoir min 2 28 35 31 37 35 46 4 36 48 36 52 43 7O 6 39 59 40 65 47 83 9 43 73 46 79 53 95 12 46 83 49 90 58 100 15 48 87 53 96 59 100 Frequency adults 12 min children hand 20 min children 3 fingers 25 min Technical and performance data 23 8 Warranty e WEINMANN offers a warranty that the product when used in accordance with requirements will remain fr from defects for a period of two years from date of purchase For products whose durability is clearly indica ted as less than two years the warranty expires on the expiration date indicated on the packaging or in the user s manual e Claims against the warranty can be made only when accompanied by the sales receipt which must show salesperson and date of purchase e We offer no warranty in the case of Disregard of usage instructions Operating errors improper use or 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
17. uction Logistics Service Weinmann Ger te f r Medizin GmbH Co KG Siebenst cken 14 D 24558 Henstedt Ulzburg T 449 0 4193 88 91 0 F 449 0 4193 88 91 450 emergency homecare diagnostics WEINM NN medical Mtechnology WM 16013j 12 08
18. uscitation child ventilation and e one of 60 mbar 60 cm H O for resuscitation via an endotracheal tube with adults Hazards in ventilating non intubated patients diaphragm PF _ trachea stomach contens of the stomach U m j An SS oni ee eso pha gus pressure gt 20cm H O pressure lt 20cm H O effect 6 Basic principle 2 Description of the resuscitator 2 1 COMBIBAG components IN Patient valve non re breathing walve TB Safety valve Squeeze bag compressable unit Intake valve The COMBIBAG resuscitator for adults and children consists of 4 working parts Patient valve The patient valve consists of e the valve body with bag adapter e inspiration cone for connection of the mask or en dotra e valve cheal tube connector diameter 22 15 mm diaphragm for separating inspiration and expiration e safety valve pressurerelief valve Safety valve The safety valve pressure relief valve consists of e the valve body with valve fittings and e white pressure marks 20 and 60 mbar cm H O and the red valve ring with white arrows and the figures 20 and 60 Because the safety valve can be accurately adjusted only by the manufacturer WEINMANN replacement is possible only with delivery of a complete unit Re moval of the safety valve is not permitted Description
19. uscitation in which as a rule some degree of hyperventi lation is desirable This is important since with prolonged resuscitation inadequate ventilation hypoventilation leads to considerable damage and ventilation with volume hyperventilation also has ser oo high frequency and excessive tidal ious drawbacks Cycles per min Tidal volume in ml Children from a body 40 60 20 35 weight of 10 kg Childgen 5 years old 20 35 150 200 Childgen 10 years old 18 25 300 400 Juveniles 16 20 300 500 Adults 12 16 500 1000 Ventilation must be carried out if spontaneous breath ing cannot be established once the airways are Operating instructions 11 4 4 Mask ventilation cleared and the patients spontaneous breathing must be assisted or controlled if it is inadequate Proceed as follows lay the patient on his back extend the head and neck pull the red ring on the COMBIBAG relief valve up wards pressure limit 20 mbar cm H O C grip left hand lifts the lower jaw back and seals the mask over the mouth and nose rhythmically squeeze and release the appropriate segment adult and infant at the recommended fre quency if necessary insert a Wendlairway through the nose or use a Guedelairway to improve access to the nasopharyngeal cavity the mask must seal tightly the red ring on the relief valve should be pushed down pressure limit 60 mbar c
Download Pdf Manuals
Related Search