Jiangsu Changmei Medtech has a total of three categories of products, including medical devices, medical equipment, OEM products. Wherein the medical device includes gastroenterology, respiratory, urology, orthopedics four subcategories. Medical devices include balloon manufacturing equipment, other equipment two subcategories. OEM products include balloon custom, medical supplies two subcategories.
Name: Particle filtering half mask FFP2 NR
Following Standard: EN 149:2001+A1:2009
Following Regulation: (EU)2016/425
Particle filtering half mask is minimum requirement as respiratory protective devices
to protect against particles except for escape purpose.
Manufacturer: Jiangsu Changmei Medtech Co.,Ltd.
How to use
1.Failure to follow all instructions and limitations could seriously reduce the effectiveness of this particle filtering half maskand could lead to illness, injury or death.
2.A properly selected particle filtering half mask is essential, before occupational use, the wearer must be trained by the employer in the correct use of the particle filtering half mask in accordance with applicable safety and health standards.
3.This particle filtering half mask does not supply the Use only in adequately ventilated is as containing sufficient oxygen to support life.
4.Discard the particle filtering half mask and replace with a new one ifexcessive clogging of the particle filtering half mask cause breathing difficulty or the particle filtering half mask becomes damaged.
5.Leave the contaminated area if dizziness, irritation or other distress occurs.
1. Do not use the particle filtering half mask or enter or stay in a contaminated area under the following circumstance:
a)Atmosphere contains less than 19.5% oxygen.
b)If you smell or taste contaminant.
c)For protection against gases or vapors.
d)Contaminants or their concentrations are unknown or immediately dangerous to life or health.
e)For sandblasting, paint-spray operations and asbestos.
f)In underwater, fire and explosive atmospheres.
2.Do not modify or misuse the mask.
3.Do not use theparticle filtering half mask with facial hair or any other conditions that may prevent a good face-seal, the requirements for leakage will not be achieved.
4.Particle filtering half mask need to be inspected prior to each use to assure there are no holes in the breathing zone other than punctures around and staples and no damaged has occurred. Enlarged holes resulting from ripped or torn filter material around staple punctures are considered damage.
5.Thisparticle filtering half mask helps protect against certain particulate contaminants but does not eliminate exposure to the risk of contracting disease or infection. Misuse may result in sickness or death.
6.This particle filtering half mask marked “NR”, shall not be used for more than one shift.
1.Open the particle filtering half mask, face to the inside of the mask, and hold the mask on each hand so that the nose clip is at the top.
2.Take out the retaining clip from the package and fasten one end of the retaining clip to one side of the mask.
3. Hold the particle filtering half mask in position over the nose and mouth, and fasten the other end of the retaining clip to the other side of the mask.
4. Adjust to a comfortable position and make the mask fit the face.
5. Bend the nose clip to make a tight seal around the nose.
a)To test the fit of the particle filtering half mask, cup both hands over the particle filtering half mask and inhale sharply. If air flow is felt in the nose area, re-adjust/tighten the nose clip.
b)If flows is felt around the edges of the particle filtering half mask, re-position the mask harness to achieve a better fit.
7.Change the particle filtering half mask immediately if breathing becomes difficult or particle filtering half mask becomes damaged or distorted.
8.Change the particle filtering half mask if a proper face seal cannot be achieved.
9.Careful observances of these instructions is an important step in safe particle filtering half mask use.
Notified Body: CCQS Certification Services Limited
Address: Block 1 Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin 15, D15 AKK1, Ireland
Manufacturer：Jiangsu Changmei Medtech Co., Ltd.
Address: No.27, Xinke West Road, Luoyang, 213104 Changzhou City, Jiangsu Province, P. R. China
This device is used endoscopically to obtain biopsy samples from digestive tract and respiratory tract.
|Model||Jaws Diameter||Channel I.D.||Working Length||Cups Shape||Coating||Needle|
E-Brochure of SpyGlass™ DS and SpyBite™ Biopsy Forceps From Boston Scientific
It is suitable for adults and adolescents in the dilation operation of digestive tract stricture under endoscopes.
It is used for the expansion and treatment of esophagus and cardia.
This device is mainly used to remove bile duct stones or foreign bodies in upper and lower digestive tract.
We specializes in the development and design of medical devices, with a particular focus on medical balloon research and production. We can provide integrated solutions of balloon and catheter related products as well as full-set production equipment according to customer requirements.
Material: PA, PEBAX, PU
Brand: Lubrizol, Arekma, Evonik
Production Environment: 100 000 Class Clean Room
Main Equipments: 2 Balloon Tube Extrusion line, 5 Balloon Neck Forming Machine, 12 Balloon Forming Machine, other equipments such as Balloon Welding Machine, Rediopaque Swaging Machine, Balloon Pleating Machine, Balloon High Pressure Seal Tester, Tip Forming Machine
Intended use:This device is mainly used for adults and adolescents in the dilation operation of digestive tract stricture under endoscopes.
Components of Kyphoplasty System Products:
Kyphoplasty System Products List (8G)
|1||Kyphoplasty Balloon Catheter||KB0210/KB0115/KB0120||1|
|3||Kyphoplasty Tool Kit||KT-00-01/KT-00-02/KT-00-03/KT-00-04||1|
Kyphoplasty Tool Kit List (8G)
|2||Puncture & Expandor device||KT-02-01||1||/||1||/|
|6||Bone cement filling device||KT-04-01||6||6||3||3|
Kyphoplasty System Products List (11G)
|1||Kyphoplasty Balloon Catheter||KB0210S/KB0115S/KB0120S||1|
|3||Kyphoplasty Tool Kit||KT-00-05/KT-00-06||1|
Kyphoplasty Tool Kit List (11G)
|1||Puncture & Expandor device||KT-07-01||2||1|
|2||Bone cement filling device||KT-08-01||6||1|
Intended use：The device is clinically used to brush cell sample.
Intended use: This device is combined use with endoscope to extract and remove foreign body in digestive tract.