Product Name: 100ml Disposable Constant-Flow-Rate Infusion Pump (CBI-M100) Model NO.: CBI-M100 Application: Medical Volume: 100ml Material: Plastic, ABS,PVC,PP Type: Infusion Pump Nominal Volume: 100ml Mean Flow Rate(Ml/H): 20./3.0/4.0 Trademark: Changsheng Transport Package: Pouch Pack Specification: ISO/CE Origin: China HS Code: 9018907000 Product Description 100ml Disposable Constant-flow-rate Infusion Pump (CBI-M100)Product Name:Disposable Infusion PumpStructure:Disposable infusion pump is consisted of silicone reservoir, filter, connector, tube, PCA, etc.Number of Registered Certificate:15041892 001Operative Standard:EN ISO 13485:2012+AC:2012, MDD 93/42/EEC Annex II Article 3Expected Usage:The product works as the persistent and default speed of charge. It's driven by silicone reservoir, it realizes minim and persistent charge by controlling the flow rate using current limiting device. Patient can append dose by medical order with the help of PCA, which realize the goal of clinical minim charge.CharacteristicsThe raw material of disposable infusion pump has no side effects to human body.Using Instructions1) Open the package after confirming that the package is in good condition and the type as well as specification is correct.2) Close the clip and then open the shell of the charge orifice, absorb the deployed liquid medicine into the asepsis injector.3) Move the card in the automatic controller when you use the type of CBI+PCA-M200.4) Open the clip to drain the air away, connect the pipe joint after confirming that some liquid outflows.Points of Attention1) Read the instruction carefully before use.2) Check whether the package is in good condition, or else it is strictly prohibited to use.3) It is only for single use, discard after use.4) The product was sterilized by epoxy ethane and assures asepsis for two years.5) The operator must obey the sterilized operating condition.6) Volume can't exceed 10% of the max volume marked on reservoir, or it may blow out.7) Its nominal flow rate was evaluated by using water for injection.8) The product is deposited under door temperature in dry condition.9) Adrenalin and CAT (calcium antagonists) are strictly prohibited for use.10) The product contains DEHP.11) Clinical medical staff should take substitute Product to avoid possibility toxicity may arise on those high-risk crowd (new arrivals, adolescent males, pregnant/nursing women).12) The product is not suitable for infusion by using fat-soluble drugs (e.g. Fat Emulsion).13) based on both domestic and overseas research materials, clinical medical staff should avoid PVC tube and drugs to be militated, the product is not available for drugs which are incompatible with PVC tube.PackageIndividual disposable infusion pump is packed by blister packing, the middle and outer package is corrugated box.StorageThe products should be stored in less than 80% relative humidity, non-corrosive gases and well-ventilated room.Description of Label1. for single use2.The product is EO sterilizedSterile Model:EO sterilization Validatedperiod of Sterilization:Two yearsManufacturing Company:Changzhou Medical Bioengineering Co., LtdAddress:Tianzhutang, Dongqing, Zhenglu Town, Wujin District, Changzhou City, 213114, ChinaPost Code:213114Tel:86-519-88966750Fax:86-519-88964890Website:www.china-changsheng.comEU Representative:Shanghai International Holding Corp. GmbH (Europe) JIN LIANGAddress:Eiffestrasse 80, 20537 Hamburg, GermanyTypeSpecificationMax Capacity(ml)Flow Rate(ml/h)Bolus(ml/time)Time Lock-out(min)With bolusCBI+PCA-M1001002.03.04.00.515CBI+PCA-M2002002.03.04.00.515CBI+PCA-M2752752.03.04.05.00.515Without bolusCBI-M1001002.03.04.0CBI-M2002002.03.04.0CBI-M2752752.03.04.05.0MultirateCBI+PCA-MR1001002,4,6, 80.515CBI+PCA-MR2002002,4,6, 80.515CBI+PCA-MR2752752,4,6, 80.515