Gima 34244 User manual

PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
PALLONI AUTOCLAVABILI IN SILICONE
SILICONE AUTOCLAVABLE RESUSCITATORS
INSUFFLATEURS EN SILICONE AUTOCLAVABLES
BOLSAS AUTOCLAVABLES DE SILICONA
BALÕES DE SILICONE AUTOCLAVÁVEIS
34244 - 34245 - 34246 - 34247
M34244-M-Rev.5-01.20
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.
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
Made in Taiwan
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15
Product description and intended use
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 for 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’ need for oxygen.
Codes 34244, 34246 and 34247 are equipped with a POP-Off valve, the model code 34245 does not
include the POP-Off valve in the standard equipment
The adult size has a Pressure Relief Valve design (as an option). When the pressure inside the bag ex-
ceeds 60 cmH20, and 40 cmH20 for infant and child bag, the Pressure Relief Valve will automatically
vent the
delivered breath tn 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 pulmonary
ventilation and advanced cardiac life support techniques. This manual provides all section assembly
drawings, some cautions and cleaning methods. Please carefully read all cautions in this manual before
use to accomplish the best effect, and pay attention to all safety warnings.
GIMA 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).
Warning & Caution
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 adminis-
tered. Failure to do so will affect the rell rate and maximum frequency capabilities.
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 pul-
monary ventilation and advanced cardiac life support techniques.
6. Prociency in the assembly, disassembly and use of this device should be demonstrated be-
fore use on a patient.
7. Always test the device in accordance with this manual after cleaning and sterilization or re-
placement of parts.
8. Always monitor airway pressure with a manometer when ventilating a patient.
9. Only qualied personnel trained in the use of positive end expiratory pressure (PEEP) should
administer PEEP with this device.
10. Always verify PEEP level and the function of the resuscitator before use on a patient.
CAUTIONS
1. If overriding the pressure relief valve, great caution must be taken not to allow the pressure in the
patients airways became too high.
2. Do not attempt to disassemble the pressure relief valve assembly. Disassembly will damage the com-
ponent.
3. Before use, clean and sterilize the entire Manual Resuscitator to your individual institution’s validat-
ed procedure for cleaning and sterilizing such equipment. After the Manual Resuscitator has been
cleaned and sterilized, test the Manual Resuscitator as directed in this manual.
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Principles of operation
Assembly view of an articial respiration system (A)
(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.
Assembly View (A)
Principle Drawing (B) - Inspiration
When compressing down the Resuscitator, it create the positive pressure and close the Intake Valve
(G), the air inside the bag pushes the Duckbill Valve (E) downward, and block the expiration port (F), and
deliver the air into the Silicone Bag then to the patient through the center of the Duckbill Valve, if the Ox-
ygen 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 motion, then send directly
into the patient’s body by compressing the silicone bag.
Principle Drawing (B) - Inspiration
Principle Drawing (C) - Exhalation
When releasing the Silicone Bag (B), push upward the Duckbill Valve and keep it in close position, so to
release the exhale air through the Exhale Valve (F).
Principle Drawing (C) - Exhalation
At the same time, the Inhale Valve (G) is opened by the expiratory pressure created by releasing 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.
To avoid excessive Oxygen ow rate and low compressing frequency causing too high pressure inside
the bag and the Reservoir, the Reservoir Valve (I) is specially designed to release the excessive air, to
keep a low rate Oxygen supply and ensure the patient’s safety.
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Principle Drawing (D)
GIMA Infant and Child Resuscitator are both equipped with Pressure Relief Valves, automatically pro-
vide and adjust the pressure in the lung, and keep it within 40 cmH2O+/- 5 cmH2O, any pressure exceed
this standard will cause the Pressure Relief Valve to jump off and push the pressure out to ensure the
patient’s safety.
Pressure Relief Valve
Pressure Relief Valve Motion
Should higher inspiratory pressure be required the pressure relief valve may be overridden by placing
the thumb ever the valve as show as follows.
Overriding the Pressure Relief Valve
Assembly View
34244
2
1
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18
34245 – 34246 - 34247
2
1
2
1
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19
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. Insert the oropharyngeal tube, keep the patient’s mouth open
to prevent tongue from occluding the airway. (Can use a mouth
opener to open his mouth) The oropharyngeal tube can be se-
lected according to the patient‘s mouth cavity size.
4. The emergency personnel should stay behind the patient’s
head, extend the head back and pull his chin upwards and
towards the emergency personnel.
Remark: If the patient already has an airway inner tube in-
serted, or has been through an airway excise resect oper-
ation, then please remove the mask, connect the Non-re-
breathing Valve connector with the airway inner tube, then
following the standard operating instruction
5. Cover the patient’s mouth and nose with the mask, and press
palm against the mask to keep it close to the patient’s face.
6. Use the other hand to press on the Resuscitator, regular-
ly compress sending with sufcient inhale/exhale frequency.
(Adult: 12-16 times, Child: 14-20 times, Infant: 35-40 times)
7. The emergency personnel should check: to ensure that the pa-
tient is ventilating properly.
• Observe rise and fall of the patient’s chest (accordingly with
the pressing on the Resuscitator).
• Check the patients lips and face color through the transparent
part of the mask.
• Check that the patient valve is working properly through the
transparent housing.
• During exhalation, check that the interior of the mask is being
fogged.
Cleaning, Disinfection and Sterilization
Notes for cleaning, disinfection and sterilization process:
• For cleaning, disinfection and sterilization process, the resuscitator must be disassembled as shown
in the gures. 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-disinfection-sterilization: For parts exposed to expiratory gases (non-
rebreathing valve) do cleaning-disinfection-sterilization after each patient. For parts not exposed to
patient expiratory gases (resuscitator body, oxygen valve, oxygen reservoir, mask) do cleaningdisin-
fection- sterilization regularly as needed to remove dust etc. If the resuscitator was used for patients/
environments with infectious diseases do the cleaning-disinfection-sterilization for the whole set of
the resuscitator.
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The cleaning-disinfection-sterilization process
The following steps are generally recommended. Select proper methods for the resuscitator parts in
question according to the table.
Cleaning methods
• Disassemble the resuscitator following the assembly view and order. Do not disassemble the pres-
sure relief valve spring, just rinse it directly.
• Wash the components thoroughly by a soft brush in warm clean tap water containing a mild detergent
(Follow manufacturer’s instruction for concentration and exposure time). Ensure that the detergent
is suitable for the component materials to avoid causing damage. See the material specications at
the end of the instructions. After washing, rinse the parts thoroughly in clean water to remove any
residues of detergent.
• An automatic washing machine with a programme designed for washing anaesthesia accessories
can be used according to the manufacturer’s instructions.
Disinfection methods
• Washing machines-heat disinfecting program: Automatic washing machines designed for medical
accessories usually also offer cycles for disinfection by heating, which you can use for the resusci-
tator set.
• Boiling: Immerse the parts in clean tap water, heat to boiling and keep for eg. 10 minutes for disinfec-
tion.
• Aldehyde or other chemical liquid (Ex.: Cidex, chemical with sodium hypochloride,..etc.): Can be used
on all parts of the resuscitator.
• Follow the instructions of the manufacturer of the chemical disinfectant for dilution and exposure
time.
After exposing the resuscitator parts to the chemical disinfectant. rinse all parts of the resuscitator set
thoroughly in clean water to remove the residues.
Notes
• Numerous brands of detergents and chemical disinfectants are available. Use only brands that are
compatible with the resuscitator materials to avoid reduction in the lifetime of the materials. See list
of materials. Follow the instructions of the manufacturer of the detergent or chemical disinfectant for
dilution and exposure time.
• Substances containing phenol should be avoided. Phenol will cause premature wear and degradation
of the materials or reduce the time use of the product.
• Promptly remove all residue of cleaning materials from the resuscitator. Residues may cause prema-
ture wear or reduce the time use of the product.
• Because it is very difcult to thoroughly rinse it afterwards it is not recommended to immerse the
oxygen reservoir in chemical disinfectants.
Sterilization methods
Note for sterilizing timing: When rst 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.
• Autoclaved sterilization max (134°C): Can be used on all parts of the resuscitator, except PVC mate-
rial products. Follow the recommendations given by the steam autoclaving manufacturer. All steam
autoclave cycles used for porous items are acceptable provided that the maximum temperature does
not exceed 273°F or 134°C. If plastic housing made by polycarbonate the maximum temperature
does not exceed 121°C (244°F).
• Ethylene oxide sterilization: Can be used on all parts of the resuscitator. Follow ethylene oxide cham-
ber manufacturer’s instruction.
• Gamma radiation sterilization: Can be used on all parts of the resuscitator. Follow gamma radiation
sterilization manufacturer’s instruction..
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Visual inspection through package assembly
1. After cleaning-inspection-sterilization process, let the resuscitator parts stay at room temperature to
dry (air dry). Wait until all parts are dry. No drying agent is needed.
2. After cleaning-disinfection-sterilization carefully inspect all parts for damage or excessive 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, eg. cracking. the parts should be replaced. Contact
your distributor for part replacement.
3. Assemble the parts following the Assembly View.
4. After assembling the resuscitator, a label should be put on to indicate the handling date.
Storage
• Far 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 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 70°C (-40°F to 158°F)
• For long-term storage or transportation the resuscitator should be kept in closed packing in a cool
place away from direct sunlight.
Visual inspection
1. After cleaning-inspection-sterilization process, let the resuscitator parts stay at room temperature to
dry [air dry). Wait until all parts are dry. No drying agent is needed.
2. After cleaning-disinfection-sterilization carefully inspect all parts for damage or excessive 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. After 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 orfolded state.
- Never excessively squee ze 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 (-40°F to 140°F).
- For long-term storage or transportation the resuscitator should be kept in closed packing in a cool
place away from direct sunlight.
Applicable
Methods
Cleaning
(Washing)
Disinfecting Autoclaving
Parts Manual
washing
Washing
machine
(WM)
WM
disinfecting
Boiling Chemicals 121°C (244°F)
Polycarbonate
134°C (273°F)
Polysulfone
A: Non-
rebreathing valve
    
Polycarbonate

Polysulfone

B: Resuscitator
body
      
C: Reservoir
valve
    
Polycarbonate

Polysulfone

D: Oxygen
reservoir
Silicone: 
PVC: 
Silicone: 
PVC: 
Silicone: 
PVC: 
Silicone: 
PVC: 
Silicone : 
PVC: 
Silicone: 
PVC: 
Silicone: 
PVC: 
E: Oxygen tubing
      
F: Mask
Silicone: 
PVC: 
Silicone: 
PVC: 
Silicone: 
PVC: 
Silicone: 
PVC: 
Silicone : 
PVC: 
Silicone: 
PVC: 
Silicone: 
PVC: 
: applicable : non applicable
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Testing the Resuscitator
The GIMA Manual Resuscitator should be tested as follows:
• When rst using the new Resuscitator
• After cleaning and sterilizing
• After any new parts have been tted
• Monthly, if the Resuscitator is not frequently used.
Equipment required: Test lung, 0-100 cmH2Omanometer (for Infant and Child resuscitators only), ow
meter, regulated gas supply, gas supply tubing.
Testing the silicone bag
1. Remove the non-rebreathing valve and the oxygen reservoir and valve (if tted).
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 sufciently, and that the intake
valve at the base of the silicone bag is correctly assembled.
Testing non-rebreathing valve
1. Connect the non-rebreathing valve to the silicone bag. Connect the test lung to the outlet on the
nonrebreathing 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 connection between the Resuscitator 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-re-
breathing valve is correctly assembled.
4. Ventilate the test lung for a minimum of 10 cycles to ensure that the Resuscitator is functioning cor-
rectly.
Inspiration must occur when the silicone bag is compressed and exhalation when the bag is released.
If not, check that the non-rebreathing valve is correctly assembled.
To check the function of the pressure relief valve (Infant and Child Resuscitators)
Connect a 0-100 cmH2O manometer to the patient outlet of the non-rebreathing valve. Compress the
bag. When the pressure relief valve activates, the manometer should read 35-45 cmH2O. If not, check
that the non-rebreathing valve is correctly assembled and does not leak. If the pressure relief valve fails
a further test, it must be replaced. Do not attempt to repair the pressure relief valve.
Testing Oxygen Reservoir / Reservoir Valve
1. Attach the reservoir to the reservoir valve assembly. Attach the silicone bag.
2. Inate the reservoir and block the reservoir port.
3. Compress the reservoir bag. Gas should escape through the safety outlet valve on the reservoir valve.
If not check that the reservoir valve is correctly assembled.
4. Connect the reservoir and reservoir valve assembly to a Resuscitator.
5. Cycle the Resuscitator through several ventilations. The safety inlet valve on the reservoir valve should
open during each rell to allow room air to enter the silicone bag. If not, check that the reservoir valve
is correctly assembled.
Note: If supplemental oxygen is not connected, the silicone bag will rell more slowly if the
reservoir is still attached.
Overall Resuscitator function
1. Fully assemble the Resuscitator (non-rebreathing valve, silicone bag, reservoir valve and oxygen res-
ervoir). Connect the Resuscitator to a supplemental gas source and connect a test lung to the patient
outlet on the non-rebreathing valve.
2. Set the supplemental gas flow to 15 liters per minute for the adult and child models; and to 10 l/m for
the infant model.
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23
3. Cycle the Resuscitator through several ventilations. The test lung should inate during inspiration and
deate during exhalation. Check for leakage at all joints and connections. Ensure that the Resusci-
tator refills promptly and properly and that all valves are operating correctly. If not, repeat the tests
above to nd where the problem lies.
Specification & Performance
Storage Temperature: -40°C (-40°F) to 60°C (140°F)
Operating Temperature: -18°C (0°F) to 50°C (122°F)
Materials
Silicone rubber Polycarbonate
silicone bag non-rebreathing valve housing
duckbill valve bag intake valve housing
apper valves reservoir valve housing
relief valve seal reservoir bag connector
infant mask adult mask shell
child mask pressure relief valve housing
adult mask bladder pressure relief valve stem
mask grommet
mask retainers
O-ring
Polyvinylchioride
oxygen reservoir bag
Stainless Steel
pressure relief valve spring
Connectors
patient port: 15 mm I.D. (F) / 22 mm O.D. (M)
SILICONE BAG INLET 23 mm I.D. (M)
reservoir valve 25 mm I.D.
intake valve port 25 mm O.D.
Supplemental gas inlet 6 mm O.D. (M)
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Technical specications and performance characteristics of the device
Dead Space Pressure Relief Valve
nonrebreathing valve 7 mL Child and infant 40±5 cmH2O
adult mask 150 mL Adult 60±10 cmH2O
child mask 95 mL
infant mask 28 mL
Stroke volume of 1350 mL 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.
Maximum Ventilatory Rates
The results were obtained under the following conditions:
Adult: VT-600mL, Compliance 0.02L/cmH2O, Resistance 20 cmH2O/L/s
Child A: VT-70mL, Compliance 0.01L/cmH2O, Resistance 20 cmH2O/L/s
Child B: :VT-300mL, Compliance 0.01L/cmH2O, Resistance 20 cmH2O/L/s
Infant A: :VT-20mL, Compliance 0.001L/cmH2O, Resistance 400 cmH2O/L/s
Infant B: :VT-70mL, Compliance 0.01L/cmH2O, Resistance 20 cmH2O/L/s
The correct ventilation frequency may vary, please follow current ventilation frequencies as recommend-
ed by AHA.
Range of delivery pressure
Adult: 60±10 cmH2O maximum (can be overridden by operator)
Child and Infant: 40±5 cmH2O maximum (can be overridden by operator}
Bag volume Stroke volume Reservoir volume Suitable body weight
Adult model 1600 mL 700 mL 2500 mL > 30 kg
Child model 500 mL 300 mL 2500 mL 7-30 kg
Infant model 280 mL 150 mL 500 mL <7 kg
Temperature
-18°C(0°F)
Cycle Rate
22°C(72°F)
Cycle Rate
50°C(122°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
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25
Stroke Volume Range
Oxygen concentration for Adult model
Values in brackets are without an oxygen reservoir.
Tidal Volume (ml) x Ventilation Rate with Reservoir [without Reservoir]
Oxygen concentration for Child model
Values in brackets are without an oxygen reservoir.
Tidal Volume (ml) x Ventilation Rate with Reservoir [without Reservoir]
Oxygen concentration for Infant model
Values in brackets are without an oxygen reservoir.
Tidal Volume (ml) x Ventilation Rate with Reservoir [without Reservoir]
Inspiratory resistance Expiratory resistance
Flow rate Flow rate
Using one hand Using two hands
Adult 700 ml 900 ml
Child 300 ml 350 ml
Infant 150 ml 225 ml
Oxygen Flow (LPM) 600x12 600x20 700x12 700x20 800x12 800x20
5 90 [45] 80 [44] 85 [44] 75 [42] 80 [41] 75 [40]
10 95 [48] 88 [46] 90 [45] 82 [43] 88 [45] 85 [43]
15 97 [55] 98 [51] 98 [52] 96 [50] 96 [50] 95 [50]
Conditions:
Compliance 0.2 (l/k/Pa), I : E ratio : 1 : 2 Temperature: 25°C
Resistance 20 cmH2O/L/s
Oxygen Flow (LPM) 150x15 150x25 250x15 250x25 300x15 300x25
2 95 [55] 91 [50] 87 [50] 83 [45] 82 [45] 80 [45]
6 96 [60] 93 [54] 90 [52] 85 [47] 85 [48] 85 [46]
10 98 [70] 96 [60] 93 [55] 88 [50] 90 [50] 88 [48]
Conditions:
Compliance 0.2 (l/k/Pa), I : E ratio : 1 : 2 Temperature: 25°C
Resistance 20 cmH2O/L/s
Oxygen Flow (LPM) 30x15 30x30 60x15 60x30 100x15 100x30
2 97 [78] 98 [75] 98 [70] 95 [65] 93 [60] 92 [55]
6 99 [82] 98 [80] 98 [75] 96 [70] 94 [66] 94 [63]
10 99 [85 99 [82] 99 [77] 98 [74] 98 [70] 98 [65]
Conditions:
Compliance 0.2 (l/k/Pa), I : E ratio : 1 : 2 Temperature: 25°C
Resistance 20 cmH2O/L/s
Resistance Resistance
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26
The GIMA Peep Valve (Accessory Series)
Terminal Positive Pressure Adjustment Valve
(for one patient use)
1. 2-10 cmH2O Terminal Positive Pressure Adjustment Valve for one patient use
2. 5-20 cmH2O Terminal Positive Pressure Adjustment Valve for one patient use
3. Terminal Positive Pressure Adjustment Valve Adaptor
Terminal Positive Pressure Adjustment Valve
2-10 cmH2O Adjustable Terminal Positive Pressure Adjustment Valve (Orange Silicone)
5-20 cmH2O Adjustable Terminal Positive Pressure Adjustment Valve (Blue Silicone)
Terminal Positive Pressure Valve Adaptor
Specification
Adjustable range: 2-10 cmH2O and 5-20 cmH2O
(+/-2 cmH2O) Flowing Capacity Adjustment 3 Lpm
Adaptor: 30 mm 22/15 mm outer dimension 22mm and 30mm
Materials: PC, Silicone, Stainless Steel
The Durable Peep Valve (User’s manual)
1. Attach the Diverter to the patient’s outlet as showed in the drawing.
2. Turn the Diverter toward the direction away from the patient or the Emergency Personnel’s position.
3. Compress the Resuscitator a few times to make sure all functions are normal after assembly.
4. Choose the proper Durable Peep Valve within the specication range. (2-10 cmH2O or 5-20 cmH2O)
5. Turn the knob of the Durable Peep Valve to the needed manometer indicated on the valve base.
6. As showed in the drawing, attach the Durable Peep Valve to the Diverter, connect the Resuscitator
patient’s outlet to the manometer and the breathing bag, press on the Resuscitator for the air ex-
change motion of the breathing bag, and adjust for the proper Durable Peep Valve pressure needed
on the Durable Peep Valve.
7. Regularly clean and sterilize before and after use.
Peep Valves are designed for use with the Resuscitator to introduce the positive pressure during the
ventilation. during the ventilation, the use of the Peep Valve will not affect inspiratory resistance or
inspiratory oxygen concentration, they can be used both during the treatment for breathing recovery
and breathing difculties. The Peep Valve must be attached to the Expiratory ow diverter on the re-
suscitator.
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GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product. This product meets high qualitative standards both as
regards the material and the production.
The warranty is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace free of charge all the defect-
ed parts due to production reasons.
Labor costs and personnel traveling expenses and packaging not included.
All components subject to wear are not included in the warranty.
The repair or replacement performed during the warranty period shall not extend the warranty. The
warranty is void in the following cases: repairs performed by unauthorized personnel or with non-orig-
inal spare parts, defects caused by negligence or incorrect use. GIMA cannot be held responsible
for malfunctioning on electronic devices or software due to outside agents such as: voltage changes,
electro-magnetic elds, radio interferences, etc. The warranty is void if the above regulations are not
observed and if the serial code (if available) has been removed, cancelled or changed.
The defected products must be returned only to the dealer the product was purchased from. Products
sent to GIMA will be rejected.
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Symbols
Medical Device complies with
Directive 93/42/EEC Product code
Expiration date
Caution: read instructions
(warnings) carefully Manufacturer Keep in a cool, dry place
Consult instructions for use Date of
manufacture
Keep away from
sunlight
Lot number