SMD HEPA User manual

HEPA

1
Instructions For Use:
• Used for Anesthesia Breathing Circuits.
• Please read this manual carefully and use the product under guidance of physician.
• Continuous use of the product should not exceed 24 hours, and shall be disposed after
one time use of each patient.
• To connect the machine side and patient side, please refer to the product diagram.
Features:
• More than 99.99% filtration efficiency for particle of 0.3μm or above.
• E/O residue less than 10 μg/g, if product be steriled.
• Filter Cytotoxic reaction less than class I, without mucous membrane irritation reaction
and skin sensitization reaction.
Machine side 22F
Luer Sampling port
Filter cavity
Patient side 22M/15F

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Ref Certificate CE / ISO
35ml
200-1500ml
22F-22M/15F
Dry: 80pa Wet: 100pa
Dead space
Tidal volume
Connector
Pressure Drop @30LPM
Dimensions Height 87mm width 74mm
53g
BFE 99.9999% VFE 99.9999%
Shell: AS Filter Medium: fiber-glass
paper
Weight
Materials
Filtration Efficiency
423-1-12B
with monitoring port

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Caution
1. If HEPA be used with humidifier, please insert a water trap between the patient and HEPA
and the humidifier should be more close to the patient.
2. Do not use the product between the patient and drug source.
3. Only can be connected to machine side.
4. It is prohibit to use if the package damage.
5. This product is sterilized for single patient use only, please destroy when it was used,
please do not repeat sterilization, don’t use it once again.
6. The connectors of equipments, which connect to patient side and machine side, shall meet
requirement of cone connectors in Y1040.1.
7. The connectors of equipments, which connect to auxiliary port, can be used with cone
connectors that meet requirement of GB/T 1962.1 or GB/T 1962.2.
8. Before this product working, please make sure each part linked strongly and without leak.
9. If without the sampling tube, please make sure that the sampling cap is tight.
10.When it is in used, if the patient with complications, he should be closely monitoring and
appropriate airway nursing management.
11. Avoid to be mixture used in different patient.
Storage:
1. The relative humidity of storage place shall below 80%.
2. Store in a cool, dry and dark place. Avoid direct sunlight.

Secured Medical Direction UK Co., Ltd.
Wayson Commercial Bldg 28 Con-naught Rd West Sheung Wan HK, P.R.C.
Secured Medical Direction UK Co., Ltd.
St. James House 13 Kensington Square W8 5HD London U.K.
www.smd-medical.com
HEPA