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ResMed Non-Vented Full Face Mask Hospital Mask User's Manual

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2. BAS ee teal ea FRIAS ha Sh HAS PAR SABHA ele ees AH S86 22 SO5356 1 MATS ResMed 2H WMAPVIRREP UES 9 AAS 0136 ok H 1 2 3 a b ZB t ETERA KER TARA AREAS BBWS See Hi FHEGEKEN GE ABLERARE The tara ZF 4 HHSBRSY RRA RRA RR RASH Ai 5
3. 70 SABMASRRADE BIRINE A cm H320 4 20 20 30 6 12 342 SH 93 42 EEC Ila CE EN ISO 14971 1S0 5356 1 ISO 594 1 1S0 10993 1 ISO 13485 0 40 cm H 0 50 0 4 cm H0 100 1 2 cm H20 158
4. NF AS BR THS TRAPAN MeSH SNA LIOR AMIR ine 70 HAAN AAS AOS A sean HA BS BRE E cm H20 4 20 20 30 6 12 342 93 42 EEC lla CE EN ISO 14971 ISO 5356 1 ISO 594 1 ISO 10993 1 1
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7. 230 105 HS 5 C2 40 C 10 95 20 CZ 60 C 10 95 co A o REF SS Q wl Q S wW NV A 60735 ResMed 60736 ResMed ERS AAHALHESHHS FS 60737 ResMed ERS AAHALHESHHS AF 60711 10 RESMED Hospital Mask ResMed HAHA ResMed HAMA SPLISH SSE
8. ISO 13485 IAE 0 2 40 cm H20 50 0 4 cm H2O 100 1 2 cm H20 Rt 158 2k B 230 105 5 C 40C 10 95 20 C 60 C 10 95 tor REF A Q FENE men Q S Sir wW mx NV pat core 60735 ResMed SAMA RILA 1 60736 ResMed SAMA ATLHSMS PRE 60737 ResMed SAMA RILSA S AZ 60711 SATS 10 11 Ex AAS ResMed Ltd Manufacturer 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ResMed Corp US Designated Agent 14040 Danielson Street Poway CA 92064 6857 USA ResMed UK Ltd EU Authorised Representative 65 Milton Park Abingdon Oxfo
9. side arm 1 Select the correct mask size using the fitting template provided on the package 2 Place the mask cushion over the patient s nose and mouth and pull the headgear over their head 3 Gently tighten the headgear straps a first pull the side straps back along the side of the patient s face b then adjust the top strap Note Make sure the side straps pass below the patient s ears The side arms on the mask bend back as you tighten the side straps Do not overtighten the straps as air fills the dual wall cushion and provides a comfortable seal 4 Connect the mask to the ventilator system and initiate air flow according to the ventilator system operating instructions 5 If air leaks around the cushion reposition the mask on the patient s face to achieve a better seal You may also need to readjust the headgear straps Removing the Mask To remove the mask squeeze one of the quick release clips and pull the mask and headgear up over the patient s head Cleaning the Mask This mask is disposable and should be discarded if heavily soiled If lightly soiled the mask may be cleaned by wiping with a 70 v v isopropyl alcohol swab Do not disassemble the mask A CAUTIONS Do not use solutions containing bleach chlorine aromatics moisturisers antibacterial agents or scented oils to clean any part of the system or air tubing These solutions may cause damage and reduce the life of the product Do not expose any part o
10. 711 Caution consult accompanying LOT documents Part number A Humidity limitation amp Manufacturer Small w Medium Large Lot number Temperature limitation Does not contain latex Single use NV Non vented Indicates a Warning or Caution and alerts you to a possible injury or explains special measures for the safe and effective use of the device Ordering Information Item ResMed Hospital NV Full Face Mask Small ResMed Hospital NV Full Face Mask Medium ResMed Hospital NV Full Face Mask Large Headgear 10 pk RESMED Hospital Mask ER EHAE ResMed ResMed 30 7 A
11. RESMED Hospital Mask NON VENTED FULL FACE MASK The ResMed Hospital NV non vented Full Face Mask is a disposable non invasive device used for channelling air flow with or without supplemental oxygen Intended Use The ResMed Hospital NV Full Face Mask is intended to be used with active exhaust valve ventilator systems to provide ventilatory assistance to patients with respiratory insufficiency and respiratory failure to be used on adult patients gt 30 kg requiring non life support ventilatory assistance for single patient use for a maximum of seven days in the hospital or clinical environment A WARNINGS and CAUTIONS This mask must not be used without qualified supervision for patients who are unable to remove the mask by themselves This mask is not for use on patients with impaired laryngeal reflexes or other conditions predisposing to aspiration in the event of regurgitation or vomiting The mask should not be worn unless the ventilator system is turned on and operating properly At a fixed rate of supplemental oxygen flow if used the inhaled oxygen concentration will vary depending on the pressure settings patient breathing pattern mask size selection and the mask leak If oxygen is used with the ventilator the oxygen flow must be turned off when the ventilator is not operating Explanation When the ventilator is not in operation and the oxygen flow is left on oxygen delivered into the ventilator t
12. f the system or tubing to direct sunlight as it may deteriorate Ifany visible deterioration of a component is apparent cracking tears etc replace the mask Technical Specifications When determining ventilator settings and in particular the tidal volume for volume cycled ventilators make appropriate allowances for mask dead space and leak Unintentional Mask Leak The Unintentional Mask Leak comprises leak between the cushion frame and elbow frame interfaces Pressure cm H30 4 20 20 30 Maximum leak L min 6 12 Dead Space Dead space is the empty volume of the mask up to the elbow The dead space of the mask varies according to cushion sizes but is less than 342 mL Standards CE designation in accordance with EC directive 93 42 EEC class lla EN ISO 14971 ISO 5356 1 ISO 594 1 ISO 10993 1 and ISO 13485 Operating Pressure 0 to 40 cm H20 Resistance Drop in pressure measured at 50 L min 0 4 cm H20 at 100 L min 1 2 cm H20 Dimensions H 158 mm W 230 mm and D 105 mm Medium Environmental Conditions Operating temperature 5 C to 40 C Operating humidity 10 95 relative humidity non condensing Storage and transport 20 C to 60 C Storage and transport humidity 10 95 relative humidity non condensing Disposal This mask contains no hazardous materials and may be disposed of in accordance with local environmental regulations English Symbols A REF 60735 60736 60737 60
13. rdshire OX14 4RX UK ResMed Offices Australia Austria Brazil China Finland France Germany Hong Kong India Japan Malaysia Netherlands New Zealand Norway Singapore Spain Sweden Switzerland UK USA see www resmed com for contact details ResMed Hospital NV Full Face Mask Protected by patents AU 775051 CA 2261790 EP 0956069 EP 1187650 US 6112746 US 6357441 US 6374826 US 6513526 US 6581602 US 6634358 US 6701927 US 7069933 Other patents pending Protected by design registrations AU 311195 AU 311196 AU 311197 EU 600762 Other desi di sana 2007 ResMed Ltd 60834 1 07 06 12
14. ubing may accumulate within the ventilator enclosure Oxygen accumulated in the ventilator enclosure will create a risk of fire This warning applies to most types of ventilators Please refrain from smoking while oxygen is in use Leak or variation in the leak may cause mistriggering of the ventilator In determining ventilator settings and in particular the tidal volume for volume cycled ventilators make appropriate allowance for mask dead space and leak As with all mask ventilation systems significant leak may occur between the mask and the patient s face The leak may vary depending on such factors as the patient ventilation potentially producing profound hypoventilation or hyperventilation The magnitude of this effect depends on the ventilator s ability to compensate English About the Mask This mask does not contain latex PVC or DEHP materials If the patient has any reaction to any part of the mask system discontinue use ResMed has tinted the Hospital NV Full Face Mask elbow blue to identify it as a non vented mask for use with active exhaust non invasive ventilator systems only The mask has a standard female 22 mm tapered fitting ISO5356 1 for external connection to the ventilator Fitting the Mask The ResMed Hospital NV Full Face Mask is supplied fully assembled Note Inspect the mask and replace it if any parts are damaged headgear side strap quick release clip Back view

ResMed Non-Vented Full Face Mask Hospital Mask User's Manual

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