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The NovaSpine Powered Suction Pump PRO-I is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patient's airway or respiratory support system either during surgery or at the patient's bedside.

The NovaSpine Powered Suction Pump PRO-I is a lightweight, self contained, portable battery powered, aspiration pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous or intermittent negative pressure. The NovaSpine Powered Suction Pump PRO-I is available in only one model: 1. Suction: 9 liters/min, 2. Maximum Vacuum: 200 mmHg 3. Noise: 35 dba, 4. Weight: 2.8 kg 5. Operation: Continuous and Intermittent 6. Dimensions: 290mmX359mmX130mm The pump is powered with a rechargeable Nickel-metal Hydride (NiMh) battery. The unit includes a port for an external power supply and/or a battery charger. The NovaSpine Powered Suction Pump PRO-I is composed of two parts: 1. The pump and battery pack are all housed in a single unit. The charging unit is a separate stand alone device. 2. The consumable/disposable components such as: a. Collection canister (secretion container), b. Related hoses (tubing) c. Hose connectors d. Filters e. Other accessories as detailed in the operating manual

The SIMEX Portable Suction / Aspirator / Vacuum system is indicated and used for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at patient's bedside.

The SIMEX Suction Pump is a lightweight portable or stationary suction/ aspirator pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous negative pressure. Applications range from hospital, medical practice, emergency care, ambulance, and in home usage. The SIMEX Suction Pumps have two Models. These Models have the same physically size and function but are differentiated in capacity as summarized below: 1. The SIMEX AC Model powered with alternating power. This Model has of three versions: a. SIMEX "AC20", i. Suction 18 1/min, ii. Noise 56 db (A), iii. Weight 3200 g, iv. Operation Continuous v. Color: Blue b. SIMEX "AC20K" i. Suction 18 1/min, ii. Noise 63 db (A), iii. Weight 3200 g, iv. Operation 20 Min v. Color: Blue c. SIMEX "AC30" i. Suction 28 1/min, ii. Noise 61 db (A), iii. Weight 3900 g, iv. Operation 30 Min v. Color: Green 2. The SIMEX DC Model using an on board battery. This Model has of three versions: a. SIMEX "DC20", i. Suction 20 1/min, ii. Noise 63 db (A), iii. Weight 3100 g, iv. Operation 20 Min v. Color: Red b. SIMEX "DC30", i. Suction 28 1/min, ii. Noise 63 db (A), iii. Weight 3500 g, iv. Operation 20 Min v. Color: Yellow c. SIMEX "DC30S" i. Suction 28 1/min, ii. Noise 62 db (A), iii. Weight 3500 g, iv. Operation 45 Min v. Color: Yellow Models designed for mounting on a panel and packaged with a special "wall holder" are so designated with the letter "W" after the model and version number, e.g., "SIMEX DC 20W". All moving and electrical components are housed in a moulded compact plastic housing (130 mmx359 mmx290 mm). The unit includes attachment for an external power supply and/or a battery charger. The vacuum is produced with a maintenance-free electrical piston or diaphragm vacuum pump. The vacuum pump transmits negative pressure throughout the tubing-system and the collection jar to a suction catheter that aspirates secretions or liquid from the body. The aspirated fluids are collected in the collection jar that is isolated from the pump by a hydrophobic filter. It also has a mechanical overflow protection in the lid of the collection jar to further prevent the fluids from being sucked into the pump. The filters are single use attachments that can be readily exchanged. The tubing and collection jar can either be replaced after use or sterilized using chemical disinfectants or can be autoclaved in accordance with the instructions supplied. Alternatively the collection jar can be replaced with a holder and a disposable aspiration bag. A secondary air valve placed in the suction system can regulate the degree of vacuum and flow rate. The actual suction capacity can be estimated from the analogue manometer mounted on the pump. The pump vacuum can be manually adjusted using the regulating valve and the vacuum gage. The device can be adjusted to low vacuum values for use in nasal, pharyngeal and tracheal areas. Note that all controls are manual and the pump does not require any electronic process control. The pump can be easily moved by hand or (versions that have a "W" designation) rapidly mounted to vehicle sides, room walls or wheel chairs. The SIMEX DC models have integrated electric supply enables charging and operation of the pump with the 12 to 24 Volts DC power supply. Also, if the units are used in home care, hospitals or clinical practices the SIMEX AC or DC models can be directly connected to AC power supplies for operation. Since neither the pump nor its components come in direct contact with the patient sterilization is not required. The SIMEX Suction Pump is composed of two parts: - 1. The pump, power unit and power supply all housed in a single unit - 2. The consumable components such as: - Collection jar (secretion container), - Related hoses (tubing) - Hose connectors The operating details of both models, SIMEX AC and SIMEX DC, are given in the operating manuals for the pumps (Product Inserts). These include detail list of all accessories that can be used with each suction pump, the part numbers, and the specifications for their use. Details regarding the assembly and disassembly of each model are given in Service Instructions. These Service Instruction are for use by trained technicians who are familiar with the product. They are not to be used by untrained end users. These instructions will not be packaged with the pump.

The NovaSpine Cement Restrictor device is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. The NovaSpine Cement Restrictoris NOT intended for any spinal indications.

The NovaSpine Cement Restrictor "NSCR" is an implanted device for use as non-load bearing cement containment in orthopedic surgery. It will be used to contain standard bone cement such as Polymethylmethacrylate (PMMA) in the diaphysical canal of the femur or tibia. The device is a straight or tapered rectangular hollow box construction with serrations on two opposite sides and flat surfaces on the remaining two sides. The device is fenestrated on all sides. The device is made in a variety of sizes the use of which will be determined by the responsible surgeon in accordance with the physical characteristics of each patient.