Gima RE-22135 User manual

PROFESSIONAL MEDICAL PRODUCTS
PALLONI AUTOCLAVABILI IN SILICONE
SILICONE AUTOCLAVABLE RESUSCITATORS
INSUFFLATEURS EN SILICONE AUTOCLAVABLES
BOLSAS AUTOCLAVABLES DE SILICONA
BALÕES DE SILICONE AUTOCLAVÁVEIS
RE-22135 (GIMA 34244)
RE-22115 (GIMA 34245)
RE-22215 (GIMA 34246)
RE-22315 (GIMA 34247)
M34244-M-Rev.6-12.23
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.
Besmed Health Business Corp.
No. 5, Lane 116, Wu-Kong 2nd Road, Wu-Ku District,
New Taipei City 24888, Taiwan
Made in Taiwan
0197
Mdi Europa Gmbh
Langenhagener Str. 71, 30855
Hannover Langenhagen, Germany
-40˚C
+60˚C
PHT
DEHP
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com

18
ENGLISH
PRODUCT DESCRIPTION AND INTENDED USE
Besmed Manual Resuscitator is designed for use as an adjunct to arcial respiraon and car-
diopulmonary resuscitaon. The Resuscitator can be used to venlate the apnoeic paent and
to augment venlaon and/or oxygen delivery to the spontaneously breathing paent. The
designs are also dierent according to Adult, Child or Infant by using dierent compressing
frequency, they also come with dierent sizes to meet all paents’ need for oxygen.
The adult size has a Pressure Relief Valve design (as an opon). When the pressure inside the bag
exceeds 60cmH20, and 40cmH20 for infant bag, the Pressure Relief Valve will automacally vent
the delivered breath to the atmosphere to protect the lung from injuring by the high pressure.
This product is intended for use by qualied medical or emergency personnel trained in pul-
monary venlaon and advanced cardiac life support techniques. This manual provides all
secon assembly drawings, numbers for all construcon parts, some cauons, and cleaning
methods. Please carefully read all cauons in this manual before use to accomplish the best
eect, and pay aenon to all safety warnings.
BESMED SILICONE RESUSCITATOR
It is manufactured by using supreme rated Silicone, with high exibility, stable material, can
resist high temperature (to a maximum of 134°C).
WARNINGS & CAUTIONS
WARNINGS
1. Do not use the Manual Resuscitator in toxic atmospheres.
2. Remove the oxygen reservoir and reservoir valve if supplemental oxygen is not being ad-
ministered. Failure to do so will aect the rell rate and maximum frequency capabilies.
3. Do not administer supplemental oxygen in the presence of open ames.
4. Do not use oil, grease or other hydrocarbon-based substances on any part of the manual
Resuscitator Supplemental oxygen, supplied under pressure, can combine with hydrocarbons
and cause explosions.
5. This device is intended for use by qualied medical and emergency personnel trained in
pulmonary venlaon and advanced cardiac life support techniques.
6. Prociency in the assembly, disassembly and use of this device should be demonstrated
before use on a paent.
7. Always test the device in accordance with this manual aer cleaning and sterilizaon or
replacement of parts.
8. Always monitor airway pressure with a manometer when venlang a paent.
9. Only qualied personnel trained in the use of posive end expirato1y pressure (PEEP)
should administer PEEP with this device.
10. Always verify PEEP level and the funcon of the resuscitator before use on a paent.
11. Monitor airway pressure with a manometer when venlang a paent.
CAUTIONS
1. If overriding the pressure relief valve, great cauon must be taken not to allow the pressure
in the paents airways to become too high.
2. Do not aempt to disassemble the pressure relief valve assembly. Disassembly will damage
the component.
3. Before use, clean and sterilize the enre Manual Resuscitator to your individual instuon’s
validated procedure for cleaning and sterilizing such equipment. Aer the Manual Resuscita-
tor has been cleaned and sterilized, test the Manual Resuscitator as directed in this manual.

19 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.
Principle Drawing (B) - Inspiraon
When compressing down the Resuscitator, it creates the posive pressure and close the In-
take Valve (G ), the air inside the bag pushes the Duckbill Valve (E) downward, and block the
expiraon port (F ) and deliver the air into the Silicone Bag then to the paent through the
center of the Duckbill Valve, if the Oxygen is in use, it should be connected by (H) part, then
the Oxygen will ll up the Reservoir through the Reservoir Valve, and installs in the Silicone
Bag through the recovery inhale moon, then send directly into the paent’s body by com-
pressing the silicone bag.
Principle Drawing (C) - Exhalaon
When releasing the Silicone Bag (B), push upward the Duckbill Valve and keep it in close posi-
on, so to release the exhale air through the Exhale Valve (F).

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At the same me, 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 me, send the Oxygen into the bag from the Oxygen Reservoir ll the bag returns to the
original shape before compressing.
To avoid excessive Oxygen ow rate and low compressing frequency causing too high pressure
inside the bag and the Reservoir, the Reservoir
Valve (C) is specially designed to release the excessive air, to keep a low rate Oxygen supply
and ensure the paent’s safety.
Principle Drawing (D)
Besmed Infant and Child Resuscitator are both equipped with Pressure Relief Valves, automa-
cally provide and adjust the pressure in the lung, and keep it within 40cmH2O+ /-5cmH 2O
, any pressure exceed this standard will cause the Pressure Relief Valve to jump o and push
the pressure out to ensure the paent’s safety.
Should higher inspiratory pressure be required the pressure relief valve may be overridden by
placing the thumb over the valve as show as follows.

21 ENGLISH
ASSEMBLY VIEW
Replacement Parts
Name Part number(old model)
1600ml Silicone Adult Resuscitator RE-22120
1600ml Silicone Adult Resuscitator W/pop-o 60cmH2O RE-22140
550ml Silicone Child Resuscitator W/pop-o 40cmH2O RE-22220
280ml Silicone Infant Resuscitator W/pop-o 40cmH2O RE-22320
1600ml Silicone Adult Resuscitator RE-23120
1600ml Silicone Adult Resuscitator W/pop-o 60cm H2O RE-23140

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ENGLISH
1000ml Silicone Adult Resuscitator W/pop-o 60cmH2O RE-23122
550ml Silicone Child Resuscitator W/pop-o 40cmH2O RE-23220
280ml Silicone Infant Resuscitator W/pop-o 40cmH2O RE-23320
1600ml Silicone Adult Resuscitator RE-24120
1600ml Silicone Adult Resuscitator W/pop-o 60cm H2O RE-24140
550ml Silicone Child Resuscitator W/pop-o 40cmH2O RE-24220
280ml Silicone Infant Resuscitator W/pop-o 40cmH2O RE-24320
1500ml Silicone Adult Resuscitator RE-27120
1500ml Silicone Adult Resuscitator W/pop-o 60cmH2O RE-27140
550ml Silicone Child Resuscitator W/pop-o 40cmH2O RE-27220
280ml Silicone Infant Resuscitator W/pop-o 40cmH2O RE-27320
Non-rebreathing Valve RE-21101 (PN-0401)
Non-rebreathing Valve 60cmH2O, W/peep valve adapter G1 RE-21135 (PN-0402)
Non-rebreathing Valve 40cmH2O , W/peep valve adapter G1 RE-21131 (PN-0403)
Non-rebreathing Valve RE-21151
Non-rebreathing Valve 60cmH2O W/peep valve adapter G1 RE-21164
Non-rebreathing Valve 40cmH2O W/peep valve adapter G1 RE-21160
Duck Bill Valve Silicone 7RE-21013-000BL (PN-0409)
Exhalaon Disc Membrane 7RE-21014-000BL (PN-0410)
Intake Valve complete (All in One) RE-21210
Peep Valve 2-10 cmH2O(30mmID) RE-21330 (PN-0042)
Peep Valve 2-10 cmH2O(15mmID) RE-21335 (PN-0042-1)
Peep Valve 5-20 cmH2O(30mmID) RE-21340 (PN-0044)
Peep Valve 5-20 cmH2O(15mmID) RE-21345 (PN-0044-1)
Oxygen Reservoir 2500 ml BR-62725 (PN-0438)
Oxygen Reservoir 600 ml BR-62706 (PN-0440)
Oxygen Reservoir 2500 ml BR-62625 (PN-0439)
Oxygen Reservoir 1000 ml BR-62610 (PN0441)
Silicone mask #0 SM-86503 (PN-0000)
Silicone mask #1 SM-86513 (PN-0001)
Silicone mask #2 SM-86523 (PN-0002)
Silicone mask #3 SM-86131(PN-0003)
Silicone mask #4 SM-86141 (PN-0004)
Silicone mask #5 SM-86151 (PN-0005)

23 ENGLISH
OPERATING INSTRUCTION
1. Place the paent on back, pull his chin upward as possible to keep the airway and the
mouth cavity in alliance line, so the paent can breathe smoothly.
2. Clean all visible foreign material inside the mouth and the throat.
3. Insert the onopharyngeal tube, keep the paent’s mouth open to prevent tongue from
occluding the airway. (Can use a mouth opener to open his mouth) The onopharyngeal tube
can be selected according to the paent’s mouth cavity size.
4. The emergency personnel should stay behind the paent’s head, extend the head back and
pull his chin upwards and towards the emergency personnel.
Remark: If the paent already has an airway inner tube inserted, or has been through an
airway excise resect operaon, then please remove the mask, connect the Non-rebreathing
Valve connector with the airway inner tube, then following the standard operang instrucon.
5. Cover the paent’s mouth and nose with the mask, and press palm against the mask to keep
it close to the paent’s face.
6. Use the other hand to press on the Resuscitator, regularly compress sending with sucient
inhale/exhale frequency. (Adult: 12 - 16 mes, Child: 14 - 20 mes, Infant: 35 - 40 mes)
7. The emergency personnel should check to ensure that the paent is venlang properly.
• Observe rise and fall of the paent’s chest (accordingly with the pressing on the Resuscitator).
• Check the paent’s lips and face color through the transparent part of the mask.
• Check that the paent valve is working properly through the transparent housing.
• During exhalaon, check that the interior of the mask is being fogged.
CLEANING, STERILIZATION:
Notes for cleaning and sterilizaon process:

24
ENGLISH
• For cleaning and sterilizaon 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-sterilizaon: For parts exposed to expiratory gases (non-re-
breathing valve) do cleaning-sterilizaon aer each paent. For parts not exposed to paent
expiratory gases (resuscitator body, oxygen valve, oxygen reservoir, mask) do cleaning-ste-
rilizaon regularly as needed to remove dust etc. If the resuscitator was used for paents /
environments with infecous diseases do the cleaning sterilizaon for the whole set of the
resuscitator.
THE CLEANING-STERILIZATION PROCESS
The following steps are generally recommended. Select proper methods for the resuscitator
parts in queson according to the table.
Cleaning methods:
 Disassemble the resuscitator following the assembly view and order.
Do not disassemble the pressure relief valve spring, just rinse it directly.
 Hand wash the resuscitator adequately to remove adhering substances from each compo-
nent while soaking in a commercially available, anionic detergent such as ANIOSYME DD1 for
10 mins. Use 1:200 rao of diluon in tepid water for each resuscitator keeping the tempe-
rature 35 °C.
 Rinse the manual resuscitator with 5 liters of water and proceed to sterilizaon step.
ANIOSYME DD1 processing parameters:
Minimum concentraon
of chemical required
Minimum
temperature
of tepid water
Minimum Contact me Rinsing techniques
Pour a 1:200 rao of
diluon in tepid water.
35℃10 minutes
* Clean the manual resuscitator
manually while soaking.
Rinse thoroughly
with 5 liters tap
water.
Follow all instrucons from the manufacturer of the pre-sterilizaon products. Any deviaon
from these instrucons may impact the performance of the product. Review all applicable
instrucons for addional warnings and cauons before proceeding to any stage.
Autoclave processing parameters:
Method Descrip-
on
Reprocess
limit
Note
Steriliza-
on
Auto-
clave
121 °C
for 20
mins
40 cycles
max.
* Inspect the manual resuscitator aer
processing. If any components are damaged, replace
the components immediately.
* Aer processing, discoloraon and a slight odor of ma-
nual resuscitator components is normal.
* The device can be rounely cleaned and disinfected
for safe use within reprocess limit.
Follow all instrucons from the manufacturer of the autoclave process. Any deviaon from
the manufacturer’s instrucons than those listed in this guide may impact the performance

25 ENGLISH
or durability of the product. Review all applicable instrucons for addional warnings and
cauons.
Sterilizaon methods:
Note for sterilizing ming: When rst use of the new resuscitator and when user changed do
sterilizaon for the resuscitator. Also when the resuscitator was used for more than 48 hours
do sterilizaon for the resuscitator.
Notes:
• Use only brands that are compable with the resuscitator materials to avoid reducon in
the lifeme of the materials. See list of materials on page 13. Follow the instrucons of the
manufacturer of the detergent or chemical disinfectant for diluon and exposure me.
• Substances containing phenol should be avoided. Phenol will cause premature wear and
degradaon of the materials or reduce the me use of the product.
• Promptly remove all residue of cleaning materials from the resuscitator. Residues may cause
premature wear or reduce the me use of the product.
• Because it is very dicult to thoroughly rinse it aerwards it is not recommended to immer-
se the oxygen reservoir in chemical disinfectants.
• Air dry out of direct sunlight for 25 min. Make sure the manual resuscitator is dry before use.
If not air-dried, please extend the air-drying me.
Sterilizing methods:
•Autoclaved sterilizaon Max 134°C: Can be used on all parts of the resuscitator, except PVC
material products. Follow the recommendaons given by the steam autoclaving manufactu-
rer. All steam autoclave cycles used for porous items are acceptable provided that the maxi-
mum temperature does not exceeded 134°C ( or 273°C) . If plasc housing made by polycar-
bonate the maximum temperature does not exceed 121°C (or 244°C)
Visual inspecon through package assembly:
1. Aer cleaning-inspecon-sterilizaon process, let the resuscitator parts stay at room tem-
perature to dry (air dry). Wait unl all parts are dry. No drying agent is needed.
2. Aer cleaning-disinfecon-sterilizaon carefully inspect all parts for damage or excessive

26
ENGLISH
wear and replace them if necessary. Some methods may cause discolouraon of rubber parts
but will not aect their lifeme. In case of material deterioraon, e.g. cracking, the parts
should be replaced. Contact your distributor for part replacement.
3. Assemble the parts following the Assembly View.
4. Aer assembling the resuscitator, a label should be put on to indicate the handling date.
Storage
• For compact storage, e.g. in an emergency case, the inlet end can be pushed halfway into
the bag.
• Never store the resuscitator in a compressed or folded state.
• Never excessively squeeze the bag during storage. When the resuscitator is ready for use it
should not be kept in direct sunlight or in a heated environment.
• Storage temperature: -40°C to 60°C
• For long-term storage or transportaon the resuscitator should be kept in closed packing in
a cool place away from direct sunlight.
TESTING THE RESUSCITATOR
The Besmed Manual Resuscitator should be tested as follows:
• When rst using the new Resuscitator
• Aer cleaning and sterilizing
• Aer any new parts have been ed
• Monthly, if the Resuscitator is not frequently used.
Equipment required: Test lung, 0-100 cmH20 manometer (for Infant and
Child resuscitators only), ow meter, regulated gas supply, gas supply tubing.
Tesng the silicone bag:
1. Remove the non-rebreathing valve and the oxygen reservoir and valve (if ed).
2. Compress the silicone bag and occlude (block) the non-rebreathing valve outlet.
3. Release the bag. The bag should expand immediately and rell. If not, check that the intake
valve at the base of the silicone bag is correctly assembled.
4. While keeping the non-rebreathing valve outlet blocked, compress the bag again. The bag
should not compress easily. If this occurs, check that you are blocking the valve suciently,
and that the intake valve at the base of the silicone bag is correctly assembled.
Tesng non-rebreathing valve
1. Connect the non-rebreathing valve to the silicone bag. Connect the test lung to the outlet
on the non-rebreathing valve.
2. Compress and hold the bag. The non-rebreathing (duckbill) valve inside the non-rebreathing
valve should open and the test lung should ll. If not, check the connecon between the Re-
suscitator and the test lung, and check that the non-rebreathing valve is correctly assembled.
3. Release the bag. The non-rebreathing (duckbill) valve should close and as the test lung de-
ates, gas should ow through the expiratory ports in the non-rebreathing valve. If not, check
that the non-rebreathing valve is correctly assembled.
4. Venlate the test lung for a minimum oen cycles to ensure that the Resuscitator is fun-
coning correctly. Inspiraon must occur when the silicone bag is compressed and exhalaon
when the bag is released. If not, check that the non-rebreathing valve is correctly assembled.
To check the funcon of the pressure relief valve (Infant and Child Resuscitators)
Connect a 0-100cmH2Omanometer to the paent outlet of the non-rebreathing
Valve. Compress the bag. When the pressure relief valve acvates, the manometer should