IFU - 1034753 Control module for Resuscitator Issue I_20_04_2011
Contents
1. Gl gay cce medilinc CONTROL MODULE FOR RESUSCITATOR GB INSTRUCTION FOR USE Document No 1034753 Date of last revision 20 04 2011 Revision No Control module for resuscitator IFU rev Page 1 9 20 04 2011 GCE Control modules for resuscitator are medical devices classified as class Ilb according to the Medical Device Directive 93 42 EEC Their Compliance with essential requirements of 93 42 EEC Medical Device Directive is based upon BS6850 2002 standard 2 Intended use The GCE Control module for resuscitator is standard used in the resuscitation set which may also contain oxygen regulator connection hoses demand valve and mask The set is used for resuscitation in emergency or ambulance field The GCE Control module for resuscitator is an automatic gas powered time cycled system with patient trigger and manual override The unit provides medical oxygen for artificial respiratory ventilation and breathing on demand The system permits conscious patients to establish their own respiratory pattern The apparatus is useable for a Child Adult resuscitation for the normal range of body masses from 20 to 60kg respectively The CPR setting however may be used for heavier body masses where appropriate The control module monitors patient breathing and automatically shuts off artificial ventilation when spontaneous ventilation occurs while continuing to provide oxygen therapy The system also covers2. the apparatus is used in a manner not conforming to its intended use GCE cannot be held responsible for the misuse of the equipment in case of non application of the instructions for use Manufactured by GCE s r o Tel 420 569 661 111 Zizkova 381 Fax 420 569 661 602 583 81 Chotebor http www gce online com 0434 Czech Republic Jea GCE s r o Control module for resuscitator IFU rev Page 9 9 20 04 2011
3. the reverse situation where should the respiratory rate drop below the pre set level the unit automatically starts artificial ventilation Once the operator has established an effective seal between the patient s face and mask the control module is ideally suited for resuscitation in a toxic environment because the system is totally sealed from the external environment 3 Operational transport and storage safety requirements p o S O k n AN e Keep the product and its associated equipments away from heat sources fire cigarettes v v v flammable materials 4 v v oil or grease v v ve water v x v dust Mv v v AN e The product and its associated equipments must be prevented from falling over AN e Always maintain oxygen cleanliness standards 7 Jf F AN e Use only the product and its associated equipments in well ventilated area v Before initial use the product should be kept in its original packaging GCE recommends use of the original packaging including internal sealing bag and caps if the product is withdraw from operation for transport storage Statutory laws rules and regulations for medical gases accident prevention and environmental protection must be observed Operation conditions Storage and transport conditions x 10 40 x 20 60 AN e Ifthe cylinder is a part of resuscitator set a maximum allowed storaged temperature is 40 C Control module for resuscitator IFU re
4. and monitor casualty s pulse pallor and pupils frequently When the casualty commences breathing the unit switches to demand flow automatically allowing the casualty to breathe unassisted through the unit Should the casualty s respiratory rate drop below the pre set levels the unit reverts to automatic mode Having successfully ventilated the casualty and established a good respiratory rate check the casualty for any further injuries medi alerts Turn the casualty into the recovery position Treat the casualty for shock Reassure the casualty and DO NOT LEAVE until the medical services arrive Use the head harness to maintain mask to face seal during transportation of the casualty If breathing and or circulation cease recommence resuscitation 6 2 3 Using resuscitator unit in cardiac arrest e Throughout resuscitation frequently monitor the casualty s pulse pallor and pupils Frequently monitor the cylinder contents gauge When the pressure drops to the mid position in the red sector replace the cylinder e When resuscitating children under 20kg gently press the trigger while watching the chest rise and fall DO NOT prolong or sustain trigger operation as over inflation may occur in extreme cases e In normal non toxic breathable air Expired Air Resuscitation should be commenced immediately if no breathing is detected and continued until the resuscitator is ready for use On arrival at the scene of the incident assess the si
5. arried out by a GCE authorised person only Any product sent back to a GCE authorised person for maintenance shall be properly packaged The purpose of the maintenance has to be clearly specified repair overall maintenance For product to be repaired a short description of fault and any reference to a claim number might be helpful e All labels on the equipment must be kept in good legible condition by the owner and the user during the entire product life time e All seals and o rings must be kept in dry dark and clean environment by the owner and the user during the entire product life time e Use only original GCE components 8 3 Maintenance report The control module for resuscitator must be maintained and examined at least once a month A report of each examination must be signed by the person conducting the examination and the report kept available for inspection Information recorded usually includes 1 The name and address of the employer responsible for the apparatus Control module for resuscitator IFU rev Page 8 9 20 04 2011 2 Particulars of the type of apparatus and of the distinguishing number or mark together with a description sufficient to identify the apparatus and the name of the maker The name of the person conducting the tests together with their signature or authentication mark The date of the examination The condition of the apparatus and the particulars of any defect found at the examination The p
6. bove 4 After the first minute check the pulse and thereafter check the pulse every 3 minutes with minimum disruption to the resuscitation sequence Checking for Response When resuscitation is successful the carotid pulse will return Look at the casualty s face and lips their colour will improve as oxygenated blood begins to circulate If the casualty is not breathing their normal colour will turn to blue cyanosis Maintain this cycle until cardiac output is achieved or ordered to stop by a medically qualified person When stable 1 Place the casualty in the recovery position and treat for shock continually reassuring the casualty throughout 2 DO NOT LEAVE the casualty until the arrival of the medical services 3 Use the head harness to maintain the mask to face seal during transportation of the casualty 4 If breathing and or breathing and circulation cease recommence resuscitation 6 2 4 List of accessories To be connected to the control module outlet Demand valve mask To be connected to the control module inlet Flexible hoses high pressure medical regulator shut off valve cylinder e Before using of any accessories make sure that it is following valid standard and is compatible with the control module and performance of the control module or the accessories wasn t negativaly affected 6 3 After use and monthly test 1 Ensure that the pin index yoke seal is clean in good condition and fully tightened 2 Open the cyli
7. he airway by extending the head and neck using a rolled blanket or coat to support the neck Check the casualty s breathing pulse pallor and pupils Listen feel and look for signs of respiration Loosen restrictive clothing at the neck chest and waist Open the case using snap fasteners Ensure the cylinder is turned ON Take the Demand Valve from the resuscitator box and connect the appropriate face mask Place adjacent to the casualty Check the airway is clear and place face mask over the casualty s face ensuring a tight seal round the nose and mouth Fig 1 Give 2 inflations to saturate the lungs with oxygen using the manual trigger Fig 1 watching the rise and fall of the chest at the same time Fig 1 Position of Mask with Trigger in use Control module for resuscitator IFU rev Page 4 9 20 04 2011 AN A A A 10 Excess pressure caused by a blocked airway possibly due to patient position or vomit will set off the relief valve and audible alarm on the demand valve Re check breathing pulse pallor and pupils If no pulse is found follow the procedure overleaf entitled Using Resuscitator Unit in Cardiac Arrest 11 12 13 14 15 16 If a pulse is present but no breathing is detected select the appropriate mode on the ventilation unit i e large adult small adult or child The unit will now ventilate automatically When used in automatic mode ensure that the airway is maintained
8. n be carried out with an alcohol based solution spray or wipes If other cleaning solutions are used check that they are not abrasive and that they are compatible the product materials including labels and gas e Do not use cleaning solutions containing ammonia e Do not immerse in water or any liquid e Do not expose to high temperature such as autoclave gt e gt 8 1 Service and Product Life time Service GCE recommend that a product Periodic inspection is undertaken every month following Section 6 3 It should be done by skilled technician GCE recommend that after 5 years of operation an Overall maintenance function is undertaken This maintenance consists of preventive maintenance operations replacement of critical components and re testing of the product Overall maintenance shall be carried out by GCE authorised person only It should not be assumed that the Periodic Inspection and Overall Maintenance period recommended by GCE cover every safety procedure or practice required by local regulations or statutory requirements or that abnormal or unusual circumstances may not warrant or suggest further requirements or additional procedures Life time Maximum life time of the product is 20 years At the end of the product s life time the product must be withdrawn from service The owner shall put in place a relevant procedure to ensure the product cannot be used again 8 2 Repairs Repairs The repairs shall be c
9. nder valve two turns anti clockwise with the key provided 3 Select CPR setting on the unit 4 Check that the contents gauge reads more than three quarters full If it does not refill or replace the cylinder 5 Close the cylinder valve watch the gauge and check that the reading has not changed after 5 seconds If the equipment fails this leak test return for servicing 6 Select Large Adult setting on the unit After a few moments the unit will operate at 18 22 cycles min 7 Block the patient port and flick the trigger Check that the airway blockage alarm sounds 8 Flick the trigger several times and ensure that there is a free flow of gas Listen carefully for leaks Release the trigger and note the time delay before ventilation resumes approximately 4 to 6 seconds 9 Close the cylinder valve and operate trigger to discharge pressurised gas 10 Carefully pack unit and accessories ready for use 11 Record details of test in accordance with Section 8 3 e Disconnect the gas supply and depressurise the system before cleaning and dismantling e DONOT dismantle the apparatus beyond the instructions in this manual unless you are fully trained and in possession of the appropriate instructions Control module for resuscitator IFU rev Page 7 9 20 04 2011 7 Cleaning A A A Remove general contamination with a soft cloth damped in oil free oxygen compatible soapy water amp rinse with clean water Disinfection ca
10. p caps in a safe place for reuse during transport or storage AN e The product is dedicated only for use with the gas specified on its labelling Never try to use for another gas 6 2 Operational instructions and accessories 6 2 1 List of recognised accessories To be connected to the control module outlet Demand valve mask To be connected to the control module inlet Flexible hoses high pressure medical regulator shut off valve cylinder 6 2 2 Using resuscitator unit in respiratory arrest e Continually check the hose for cranking and necking The patient must be under continual control during using the device e During resuscitation frequently monitor the casualty s pulse pallor and pupils Frequently monitor the cylinder contents gauge When the pressure drops to the mid position in the red sector replace the e When resuscitating children under 20kg gently press the trigger while watching the chest rise and fall DO NOT prolong or sustain trigger operation as over inflation may occur in extreme cases e In normal non toxic breathable air Expired Air Resuscitation should be commenced immediately if no breathing is detected and continued until the resuscitator is ready for use A A lind A A On arrival at the scene of the incident assess the situation for danger to yourself and the casualty then 1 2 A pa D Ensure that the casualty s mouth is clear of debris vomit and loose dentures Open and maintain t
11. ressure of oxygen in the supply cylinder oo A Breathing Apparatus Log Book Article Number 1034745 is available from GCE for recording this information 9 Glossary Suitable for Home care use Upper and lower humidity limit Suitable for Hospital care use we Keep away from oil and grease Suitable for Emergency care use Keep away from heat and flammable material Keep dry Upper and lower temperature limit 4 8 8 SN Serial number Date of manufacture Manufacturer ECS LOT Batch number REF Reference number 10 Warranty GCE guarantees the control module for one year or in accordance with statutory warranty rights from date of delivery against faulty design material amp workmanship GCE shall not be liable for loss of production loss of profit or any other consequential damage or indirect loss In the event of any fault in the goods due to defective design materials or workmanship our liability is limited to replacement of these goods provided that written notification is given to GCE within three months of the date of delivery or deemed delivery or such shorter time as may be specified in the quotation Goods returned to GCE will not be accepted unless GCE written consent to their return has previously been obtained The liability of the contro module is irrevocably transferred to the owner or operator to the extent that it is modified serviced or repaired by personnel not employed or authorised by GCE or if
12. roduct performance SETTING BODY WEIGHT TIDAL VOLUMES 15ml kg Large Adult 60kg nominal 900ml Small Adult 40kg nominal 600ml Child 20kg nominal 300ml CPR SETTING 0 to 120L min maximum 100L min typical Nominal setting as measured on GCE Resuscitation set FREQUENCY RANGE 18 to 22 Cycles min INHALATION EXHALATION RATIO 1 2 Nominal PAUSE TIME RELEVANT TO REVERT TO 4 t06 nds approximate AUTOMATIC VENTILATION eee WEIGHT 1 2kg 2 6lbs Note Specification values are approximate The manufacturer reserves the right to change these values without prior notification 6 Operations 6 1 Before use Visual Inspection before use Check if there is visible external damage to the product including product labels and marking If it shows signs of external damages remove it from service and identify its status Visually check if the product is contaminated if needed use the cleaning procedure detailed in this section Check if the product service is due or that the total life time of the product and the gas cylinder has not been exceeded refer to GCE or owner s date coding system If service or life time has been exceeded remove the product from service amp suitably identify its status Control module for resuscitator IFU rev Page 3 9 20 04 2011 e Ensure that the product inlet connector is compatible with the low pressure source of medical gas AN e Remove caps from inlet and or flow outlet Kee
13. s at the bottom of the breast bone Fig 4 then place the heel of the other on top Fig 5 13 Keep fingers off the chest lock your arms at the elbows and apply firm controlled vertical pressure to compress the Sternum to a maximum of 40mm to 50mm 1 5 to 2 inches Sternum Position of Heart Position of heel of Hand Rib Cage Solar Plexus Fig 4 Hand Position over Heart One man operation 15 Compresions 2 Ventilations Check pulse 1 Complete 15 compressions at the rate of 80 per minute The compressions should be regular and smooth not jerky and jabbing 2 Tilt the casualty s head back and check airway is clear Control module for resuscit 20 04 2011 A gt gt Fig 5 Attitude of Hands 3 Use the trigger to give TWO ventilations of the lungs Fig 1 continue with 15 compressions and again 2 ventilations Continue repeating the cycle as above 4 After the first minute check the pulse and thereafter check the pulse every 3 minutes with minimum disruption to the resuscitation sequence Two man operation 5 Compresions 1 Ventilations Check pulse 1 Complete 5 compressions at the rate of 80 per minute The compressions should be regular and smooth not jerky and jabbing 2 Tilt the casualty s head back and check that the airway is clear 3 Use the trigger to give ONE ventilation of the lungs Fig 1 continue with 5 compressions and again 1 ventilation Continue repeating the cycle as a
14. tuation for danger to yourself and the casualty then 1 2 oe ee Oo Ensure that the casualty s mouth is clear of debris vomit and loose dentures Open and maintain the airway by extending the head and neck using a rolled blanket or coat to support the neck Loosen restrictive clothing at the neck chest and waist Check breathing pulse pallor and pupils Listen feel and check for signs of respiration Open the case using snap fasteners Ensure the cylinder is turned ON Take the Demand Valve from the resuscitator box and connect the appropriate face mask Place adjacent to the casualty Select CPR mode on the control module Check the airway and place the face mask over the casualty s face ensuring a tight seal round the nose and mouth Fig 2 Fig 2 Position of Mask with Trigger in use Control module for resuscitator IFU rev Page 5 9 20 04 2011 10 Use the manual trigger to give 2 inflations that will saturate the lungs with oxygen Fig 2 whilst watching the rise and fall of the chest 11 Check the carotid pulse in the neck Fig 3 AN e The pulse at the wrist is unreliable If a pulse is present but no breathing is detected follow the procedure in Section 6 2 2 entitled Position of pulse Fig 3 Position of pulse Using Resuscitator Unit in Respiratory Arrest 12 If a pulse is not detected place the heel of one hand two finger widths up from Solar Plexus at the junction of the rib margin
15. v Page 2 9 20 04 2011 4 Personnel instructions and training According to Medical Devices Directive 93 42 EEC the producer must ensure that all personnel handling the product are provided with the operating instructions amp performance data The control module for resuscitator should be used by personnel with medical education medical man paramedical worker nurse who have received adequate training in Cardio Pulmonary Resuscitation CPR and the correct use of the resuscitator apparatus Trainees need to be supervised by an experienced person 5 Product description and performance 5 1 Product description A Inlet connection Connection by low pressure hose with gas specific connector following regional or national standards to the source of low pressure oxygen the medical O2 regulator ordinary Before using make sure that the connection between control module and low pressure source is posible flow through is available and no leakage appear B Outlet connection It is the patient side of the control module used for connection the demand valve with mask The connection is realyzed by hose nipples Before use make sure that hose nipples are compatible with the used hosess O Hanwheel of the mode selector Mode selector which allows the seting of the control module function CPR Cardio Pulmonary Resuscitation Large adult small adult child automatic ventilation mode following casualty body mass 5 2 P
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