Gima 34277 User manual

PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
PALLONE RIANIMATORE MONOUSO
DISPOSABLE RESUSCITATOR BAG
INSUFFLATEUR DE REANIMATION MONOUSAGE
BALON DE REANIMACION MONOUSO
34277 - 34248 - 34249
M34277-M-Rev.4.10.18
Manuale d’uso - User manual
Manuel de l’utilisateur - Guía de uso
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.
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
Made in Taiwan
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Product Description:
Gima Manual Resuscitator is designed for use as an adjunct to articial respiration and cardiopulmonary
resuscitation. The resuscitator can be used to ventilate the apnoeic patient and to augment ventilation
and oxygen delivery to the spontaneously breathing patient. The designs are also different according to
adult, child and infant by using different compressing frequency. They also come with different sizes to
meet all patients’ need for oxygen.
Instruction for use
- Connect the oxygen tube to an adjustable oxygen source.
- In case it is connected to a reservoir, adjust the oxygen emission so that the reservoir completely
expands during inhalation and almost completely empties during expiration thus recharging the bag.
- Before using the product, check for its efciency preferably connecting it to a test lung: check that the
connections, the reservoir, if present, and the valves complete the wjole ventilation cycle correctly.
- In case of need connect the face mask to the apposite connector.
- Follow the necessary ventilation and cardiac resucitation.
- Press the bag and observe the thorax expand during inhalation.
- Release the pressure on the bag and observe the thorax reduce during expiration.
While ventilating check for:
- Cyanosis symptoms.
- The correctness of the applied ventilation method.
- The airway pressure.
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- The correct operation of all valves.
- The correct operation of the reserve and the oxygen tube.
During ventilation the non-return valve could contaminate with vomit, blood or other secretions. In this
case, stop ventilation and proceed as follows:
- Rapidly compress the bag several times so that to expel the substance through strong jets of air.
If the non return valve is not clean yet:
- Dip the valve in the water and rapidly compress the bag several times with strong jets of air.
If the valve is still obstructed, throw out the bag.
Prescriptions
- Do not use the bag in presence of toxic substances.
- Remove the oxygen reserve and the supplementary valve if oxygen is not being given. The non-
removal reduces the recharge speed and consequently the ventilation frequency.
- Do not give supplementary oxygen in presence of free ames.
- Do not use oil, grease or other hydrocarbon containing substances on the bag and its components.
The supplementary oxygen, given under pressure, can cause explosions if mixed with hydrocarbons.
- The use of this device is reserved to qualied medical personnel trained in lung ventilation and cardiac
resuscitation advanced techniques.
- Before using the device on patients, make sure you are able to assemble, disassemble and use it.
- During ventilation, always check the airways pressure with a pressure gauge
Specification
Connectors:
patient port 15 mm l.D.(F)/22 mm O.D.(M)
SILICONE BAG INLET 23 mm |.D.(M)
reservoir valve 23 mm |.D.(F) (to silicone bag inlet)
25 mm O.D.(M) (to oxygen reservoir)
supplemental gas
inlet 6 mm O.D.(M)
Shelf Life 5 years
Dead Space: Pressure Relief Valve:
non-rebreathing valve 7ml Child and infant 40 ± 5cmH2O
adult mask 150ml Adult 60 ± 10cmH2O
child mask 95ml
infant mask 28ml
Stroke volume of 1350ml can be achieved using two hands
Minimum Cycle Rate Oxygen Concentration:
Adult 20 breaths/min with reservoir 99%
Child 20 breaths/min without reservoir 45% (adult and child models)
Infant 40 breaths/min 90% (infant model)
The performance characteristics for Manual Resuscitators will vary from user to user depending on a
variety of factors: ambient temperature, patient lung compliance, ventilatory frequency, size of opera-
tor's hands.
Bag volume Stroke volume Reservoir volume Suitable body weight
Adult Model 1600ml 700ml 2500ml > 30 kg
Child model 500ml 300ml 2500ml 7-30 kg
Infant model 280ml 150ml 500ml <7 kg
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Maximum Ventilatory Rates
The results were obtained under the following conditions:
Adult: Vr-600mL, Compliance 0.02L/cmH2O, Resistance 20cm H20/L/s
Child A: Vr-70mL, Compliance 0.01L/cmH2O, Resistance 20cm H20/L/s
Child B: Vr-300mL, Compliance 0.01L/cmH2O, Resistance 20cm H20/L/s
Infant A: Vr-20mL, Compliance 0.001L/cmH2O, Resistance 400cm H20/L/s
Infant B: Vr-70mL, Compliance O.01L/cmH2O, Resistance 20cm H20/L/s
The correct ventilation frequency may vary, please follow current ventilation frequencies as recommen-
ded by major specialist associations.
Range of delivery pressure
Adult: 6O±10cm H2O maximum (can be overridden by operator)
Child and infant: 40±5 cm H2O maximum (can be overridden by operator)
Indication for use:
Gima single use manual resuscitators are indicated to temporarily augment ventilation in patients.
Gima Silicone manual Resuscitators are intended to provide emergency ventilation or ventilation during
patient transport, with air or air enriched with oxygen. The infant model is intended for patients weighing
up to 10 kg, the child model is intended for patients weighing between 10 and 30 kg, and the adult
model is intended for patients weighing more than 30 kg.
Warning:
1. The product should be placed in a dry and clean place and sealed conditions.
2. The operator should be trained and know the skill in CPR resuscitation.
Precautions:
• The patient should be closely monitored by qualied medical personnel when using this device.
• This product is hygienically packed.
• Disposable product.
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Symbols
Product complies
with European Directive Product code
Expiration date
(see box / package)
Read instructions carefully Manufacturer Keep in a cool, dry place
Please read instructions
carefully
Date of
manufacture Keep away from sunlight
Lot number
Disposable device,
do not re-use
-18°C (0°F)
Cycle Rate
22°C (72°F)
Cycle Rate
22°C (72°F)
Cycle Rate
Adult 20 20 20
Child A 30 30 30
Child B 20 20 20
Infant A 60 60 60
Infant B 40 40 40