(B) INSTRUCTIONS FOR USE : (STERILE PRODUCTS)
Strictly refer these instructions before the use of any of our products.
Refer the label on the packaging for complete specifications of the product.
Carefully store the implant in its unopened protective packing. Before unpacking check the packing for damage. If the internal packing is damaged, implant sterility cannot be guaranteed. Do not unpack the implant until immediately before use. Check the implant as specified on the packing label. Check the implant visually for damage. Never use a damaged implant. Never reuse an implant. Modular components are part of a system. Use them only in combination with the appropriate original components made by NRV. .For details of specified combinations, see the relevant brochures and product descriptions.
All components are packed singly, in protective sterile packing. Sterile packing is marked “STERILE”. All packing conforms to European standards and regulations. Products marked “STERILE” have been sterilized by gamma radiation of at least 25kGy (2.5Mrad) and at most 35kGy (3.5Mrad).Inward-goods inspection is strongly recommended. Only intact packing protects the implant against outside influence and ensures sterile storage. Strictly observe the local regulations for asepsis when you remove the implant from its packing. The manufacturer or local distributor cannot accept returned implants except in their original, undamaged, and totally intact packing. If the packing seal is broken or the packing is opened improperly, the manufacturer cannot guarantee sterility and cannot be held liable. Before you open sterile packing, check the implant’s size by simulation with the trial implants or by verification with preoperative planning.
Store the product in a dry place at room temperature. The sterilization dot must be red. On no account use the implant after its expiry date.
Metal components that have not been implanted and that are undamaged may be re-sterilized. They can also be sterilized by the hospital’s usual sterilizing procedures, such as autoclaving. Components that are assembled in the operating theatre must be sterilized separately and suitably packed to prevent damage. Sterilize components supplied in a protective cotton sheath. Check the sterilization procedure at frequent and regular intervals. In re-sterilization by gamma irradiation, the dosis must be at least 25 kGy. Re-sterilization by further gamma radiation of UHMWPE components causes the material to deteriorate and is therefore not permissible. PE components must be re-sterilized once only by gas, such as ethylene oxide, without altering the properties of the material. In such cases, always determine the time required for sterilization and airing, but on no account exceed a temperature of 80 degree Celsius. “The above recommendations are purely for information. NRV Ortho cannot accept any responsibility for implants re-sterilized by the customer.”
Preoperative planning provides information for the choice of a suitable implant and of possible combinations. Suitable instruments, trial components (if provided for), and additional sizes of implants should always be available.
Acute or chronic local or systemic infection. Severe muscular, nervous, and/or vascular disorders that could endanger the limb. Insufficient bone substance and/or inadequate bone quality that could endanger the stable fixation of the implant. Any concomitant illness and/or dependence that could be risk implanting function. Excessive bodily activities that could cause overloading of the implant.
SIDE EFFECTS, POSSIBLE NEGATIVE EFFECTS:
With good preoperative planning, careful surgical technique and pre-, intra-, and postoperative observance of both the general and particular duty of care, the biological and mechanical result should be at least as good as that obtained from established systems currently in use. Severe osteoporosis, severe malformations, local bone tumors, metabolic disorders, infections, severe falls, drug and/or alcohol abuse, overweight, and excessive vibration stress on implants can have a negative effect on the result. Possible well known effects are * Loosening and drifting of the implant. * Dislocation of the implant. * Infection. * Venous thrombosis and pulmonary embolism. * Cardiovascular Disorders. * Hematoma.
Before surgery, check whether the patient might be abnormally sensitive or have possible allergic reactions to the implant material, and at all cost, take these into account. Patients with steel implants should not come in contact with areas with electromagnetic/magnetic field effects.
The use of the implant requires a thorough knowledge of the instruments and adequate training and experience of the implant technique.
The product label gives details of the exact set of materials used in the implant.
NOTES AND WARNINGS:
Always check that the components are perfectly clean, dry, and free of damages or residues. It is extremely important to tell the patient before surgery what factors could prejudice the success of the operation. Record the fact that you have told him/her this. Only adequately trained surgeons with sufficient experience of the implant technique should use this implant. Failure to observe these instructions renders any liability by the manufacturer null and void. The surgeon is solely responsible for the choice and use of the implant.
To ensure the implant’s traceability at all times, attach/mention the information (batch no., etc) given in the product label to the patient’s clinical history. Further information on the use of this product is obtainable on request from NRV OrthoTech Pvt. Ltd. or your local Authorized distributor.
In case of any queries, please put in to the knowledge of following organization.
NRV OrthoTech Pvt. Ltd.
C-506, Signature 2 Business Park,
Nr.Sanand Circle, S.G.Highway, Sarkhej, Ahmedabad – 382210
PH : 0091-79-66173506
Email : firstname.lastname@example.org