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PROFESSIONAL MEDIC AL PRODUC TS
PALLONI AUTOCLAVABILI IN SILICONE
SILICONE AUTOCLAVABLE RESUSCITATORS
INSUFFLATEURS EN SILICONE AUTOCLAVABLES
BOLSAS AUTOCLAVABLES DE SILICONA
BALÕES DE SILICONE AUTOCLAVÁVEIS
Manuale d'uso - User manual
Manuel de l'utilisateur - Guía de uso
Guia para utilização
ATTENZIONE: Gli operatori devono leggere e capire
completamente questo manuale prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read and completely
understand the present manual before using the product.
AVIS: Les opérateurs doivent lire et bien
comprendre ce manuel avant d'utiliser le produit.
ATENCIÓN: Los operadores tienen que leer y entender completamente
este manual antes de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender
completamente este manual antes de usar o produto.
RE-22135 (GIMA 34244)
RE-22115 (GIMA 34245)
RE-22215 (GIMA 34246)
RE-22315 (GIMA 34247)
Besmed Health Business Corp.
No. 5, Lane 116, Wu-Kong 2nd Road, Wu-Ku District,
New Taipei City 24888, Taiwan
Made in Taiwan
Mdi Europa Gmbh
Langenhagener Str. 71, 30855
Hannover Langenhagen, Germany
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
0197
+60˚C
PHT
DEHP
-40˚C
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Table of Contents
Related Manuals for Gima RE-22135
Summary of Contents for Gima RE-22135
- Page 1 ATENCIÓN: Los operadores tienen que leer y entender completamente este manual antes de utilizar el producto. ATENÇÃO: Os operadores devem ler e entender completamente este manual antes de usar o produto. RE-22135 (GIMA 34244) RE-22115 (GIMA 34245) RE-22215 (GIMA 34246) RE-22315 (GIMA 34247) Besmed Health Business Corp.
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Page 2: Product Description And Intended Use
ENGLISH PRODUCT DESCRIPTION AND INTENDED USE Besmed Manual Resuscitator is designed for use as an adjunct to artificial respiration and car- diopulmonary resuscitation. The Resuscitator can be used to ventilate the apnoeic patient and to augment ventilation and/or oxygen delivery to the spontaneously breathing patient. The designs are also different according to Adult, Child or Infant by using different compressing frequency, they also come with different sizes to meet all patients’... -
Page 3: Principles Of Operation
ENGLISH PRINCIPLES OF OPERATION Assembly View (A) Besmed Resuscitator is composed in 4 components (A) Non-rebreathing (duckbill) Valve (B) Silicone Bag (C) Reservoir Valve (D) Oxygen Reservoir The Reservoir Valve and the Oxygen Reservoir should be removed if supplemental oxygen is not to be supplied. - Page 4 ENGLISH At the same time, the Inhale Valve (G) is opened by the expiratory pressure created by relea- sing the bag, and send the air into the bag through the top of the Reservoir Valve, and at the same time, send the Oxygen into the bag from the Oxygen Reservoir till the bag returns to the original shape before compressing.
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Page 5: Assembly View
ENGLISH ASSEMBLY VIEW Replacement Parts Name Part number(old model) 1600ml Silicone Adult Resuscitator RE-22120 1600ml Silicone Adult Resuscitator W/pop-off 60cmH2O RE-22140 550ml Silicone Child Resuscitator W/pop-off 40cmH2O RE-22220 280ml Silicone Infant Resuscitator W/pop-off 40cmH2O RE-22320 1600ml Silicone Adult Resuscitator RE-23120 1600ml Silicone Adult Resuscitator W/pop-off 60cm H2O RE-23140... - Page 6 ENGLISH 1000ml Silicone Adult Resuscitator W/pop-off 60cmH2O RE-23122 550ml Silicone Child Resuscitator W/pop-off 40cmH2O RE-23220 280ml Silicone Infant Resuscitator W/pop-off 40cmH2O RE-23320 1600ml Silicone Adult Resuscitator RE-24120 1600ml Silicone Adult Resuscitator W/pop-off 60cm H2O RE-24140 550ml Silicone Child Resuscitator W/pop-off 40cmH2O RE-24220 280ml Silicone Infant Resuscitator W/pop-off 40cmH2O RE-24320...
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Page 7: Cleaning, Sterilization
ENGLISH OPERATING INSTRUCTION 1. Place the patient on back, pull his chin upward as possible to keep the airway and the mouth cavity in alliance line, so the patient can breathe smoothly. 2. Clean all visible foreign material inside the mouth and the throat. 3. - Page 8 ENGLISH • For cleaning and sterilization process, the resuscitator must be disassembled as shown in page 6. See the assembly view and table for disassembling the resuscitator set. Do not disas- semble the parts further as shown. • When and parts for cleaning-sterilization: For parts exposed to expiratory gases (non-re- breathing valve) do cleaning-sterilization after each patient.
- Page 9 ENGLISH or durability of the product. Review all applicable instructions for additional warnings and cautions. Sterilization methods: Note for sterilizing timing: When first use of the new resuscitator and when user changed do sterilization for the resuscitator. Also when the resuscitator was used for more than 48 hours do sterilization for the resuscitator.
- Page 10 ENGLISH wear and replace them if necessary. Some methods may cause discolouration of rubber parts but will not affect their lifetime. In case of material deterioration, e.g. cracking, the parts should be replaced. Contact your distributor for part replacement. 3. Assemble the parts following the Assembly View. 4.
- Page 11 ENGLISH read35-45cmH2O. If not, check that the non-rebreathing valve is correctly assembled and does not leak. If the pressure relief valve fails a fu1ther test, it must be replaced. Do not at- tempt to repair the pressure relief valve. Testing Oxygen Reservoir / Reservoir Valve 1.
- Page 12 ENGLISH Connectors: Patient port ID: 15mm ; OD: 22mm Silicone bag inlet ID: 23 mm Reservoir valve ID: 25 mm Intake valve port OD: 25mm Supplemental gas inlet OD: 6mm Dead Space: Pressure Relief Valve: nonrebreathing valve <5.5ml Child and infant 40±5cmH2O adult mask 150ml...
- Page 13 ENGLISH Infant A: VT -20mL, Compliance 0.001L/cmH2O , Resistance 400cm H2O / L / s Infant B: VT- 70mL , Compliance 0.01L/cmH2O , Resistance 20cm H2O / L /s The correct ventilation frequency may vary, please follow current ventilation frequencies as recommended by AHA.
- Page 14 ENGLISH Terminal Positive Pressure Adjustment Valve (for one patient use) 1. 2-10cmH2O Terminal Positive Pressure Adjustment Valve for one patient use 2. 5-20cmH2O Terminal Positive Pressure Adjustment Valve for one patient use 3. Terminal Positive Pressure Adjustment Valve Adaptor Terminal Positive Pressure Adjustment Valve (article name, number and specification) 2-10cmH2O Adjustable Terminal Positive Pressure Adjustment Valve (Orange Silicone)
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Page 15: Legend Of Symbols
Keep in a cool, dry place (see box / package) Authorized representative in Keep away from sunlight the European community Not made with natural rubber latex No-DEHP formulation DEHP Temperature limit Non-sterile Medical Device GIMA WARRANTY TERMS The Gima 12-month standard B2B warranty applies.
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