Gima ZINC-OINTMENT ELASTIC BANDAGE 10 cm x 10 m User guide

NIKA®-Cast / NIKA®-Zink
Zinc Paste Bandages
Instructions for use
This product may only be used in combination with the corres­ponding original products or with third-party products approved by the manufacturer for this application according to the instruc­tions and recommendations of NIKA® Medical Produkte GmbH. If third-party products which are not approved for this application by NIKA® Medical Produkte GmbH will be used in combination with products of NIKA® Medical Produkte GmbH the warranty will ex­pire and any other express or implied obligations of NIKA® Medical Produkte GmbH will become null and void. The user of NIKA® Medical Produkte GmbH products has to determine whether the product is suitable for a specific patient under the present circum­stances. NIKA® Medical Produkte GmbH will not be responsible, either express or implied, for direct or indirect damages, penalty including compensation or any other damages which may occur by or in combination with errors associated with professional judgment or application within the framework of the use of NIKA® Medical Produkte GmbH products. Furthermore, the user is obliged to inform himself regularly about the latest developments regarding this product of NIKA® Medical Produkte GmbH product and its application. In case of doubt NIKA® Medical Produkte GmbH has to be contacted. Since the use of the product rests on the user’s control he himself will be responsible. NIKA® Medical Produkte GmbH will assume no liability for damages resulting from the use of the product. We would like to point out that some products listed in this user’s instruction may not be licensed or approved for sale in all markets.
APPLICATION RANGE OF THE USERS INSTRUCTION
This user’s instruction is valid for the products described.
Table 1: Application Range of the User’s Instruction
REF
Pharmacy No.
Product Size
NIKA®-Cast elastic Zinc Paste Bandage
620406
13913914
4m x 6cm
620805
-
5m x 8cm
621005
02465996
5m x 10cm
620607
-
7m x 6cm
620807
02646539
7m x 8cm
621007
02466004
7m x 10cm
621010
02466010
10m x 10cm
NIKA®-Zink non-elastic Zinc Paste Bandage
601005
02465861
5m x 10cm
601007
02465890
7m x 10cm
601010
02465909
10m x 10cm
PRODUCT INFORMATION
General Product Information
The present product is a viscose compress impregnated with zinc paste which is provided in airtight packaging and will harden in the ambient air when it is used.
INTENDED USE, INDICATIONS AND CONTRA-INDICATIONS
Intended Use
The non-sterile zinc bandage compress is purposed for wrapping body parts with intact skin if indicated correspondingly.
Indications
Zinc paste bandages may be used in the presence of the following indications:
Muscle soreness
Muscle strains
Torn muscle fibres
Contusions
Sprains
Post-traumatic swellings
Sports trauma involving tendons, muscles or joints.
Contra-indications
Zinc paste bandages may not be used in case of the following contra-indications:
existing hypersensitivity or allergy to zinc oxide
existing hypersensitivity or allergy to any other product
ingredient
no application on open wounds
If during the treatment other components are used which are not covered by the scope of these instruc­tions for use, the corresponding instructions for use have to be checked carefully in advance.
GENERAL INFORMATION
100% guarantee of treatment success cannot be granted when using the products described in these instructions for use. Ignoring potentially specified restrictions of use and procedures may lead to malfunction.
Close cooperation between all involved persons from the medical sector and the patient himself is essential for successful treatment.
Improper handling may lead to damage of the product or to complications. Therefore, the products have to be used only by appropriately trained staff with corresponding knowledge and skills.
APPLICATION
Preparation
1. Before applying the zinc paste bandage the limb has to
be elevated until it shrinks and the corresponding body region must be thoroughly cleaned and greased.
2. Then the skin has to be covered with a padding bandage
(NIKA®-Flex or NIKA®-foam bandage) before the zinc paste bandage will be applied.
3. Pressure-sensitive areas (ridge of the tibia, ankle, back
of the foot) can be padded additionally.
Bandaging
1. The zinc paste bandage must be applied under even
tension in steep spiral turns, starting at the basal joints upwards to the joint.
2. Free areas of the limb in question must be covered with
further spiral turns.
3. Knee or elbow joint should not be bandaged for the
sake of flexibility.
Make sure that the bandage will be unrolled directly at the limb with pressure from the entire bandage width to avoid constriction and pressure edges.
4. To protect the clothing an elastic gauze bandage (NIKA®
gauze or a stockinette e.g. NIKA®-Fast or NIKA®-Tricot) can be pulled over the zinc paste bandage.
5. To obtain compression a NIKA® ideal bandage or a
NIKA®-Grip compression tubular bandage may be used.
6. Immediately after the zinc paste bandage has been
applied the patient can move around.
Follow-up
The attending physician is responsible for the change of the bandage and the follow-up. Usually the first bandage will be renewed after 2 to 6 days.
HANDLING AND STORAGE INFORMATION
The product must be always protected from sunlight and must be stored in a dry place. Storage at room temperature is re­commended.
After the expiry date the product must no longer be used and must be disposed of properly.
NOTIFICATION OBLIGATION
All serious incidents which occured by using the product (defined as „incidents which have led, could have led or could lead directly or indirectly to death or serious deterioration in the condition of a patient, a user or any other person) have to be reported immediately by the user to the manufacturer and to the Federal Institute for Drugs and Medical Devices at
hiips://www2.bfarm.de/medprod/mpsv/ .
FURTHER INFORMATION
Information on Components
Basic bandage: viscose und polyamide Zinc paste: water, glycerine, zinc-oxide, carboxy-methylcellulose,
gelatin and preservatives
Disposal
Disposal of the product has to be carried out in accordance with the local and environmental regulations taking into account the individual contamination level.
NIKA® Medical Produkte GmbH Breiten Dyk 25a; D-47803 Krefeld Tel.: 02151-513513; krefeld@nikamed.de www.nikamed.de
EXPLANATION OF SYMBOLS
Manufacturer
Country and date of manu-
facture
Instructions for use
Do not reuse
Attention
Expiry date
Medical Device
Reference Number
Lot Number
Uniqe Device Identifier
Keep away from sunlight
Keep in a dry place
– All rights reserved –
© NIKA® Medical Produkte GmbH 2021
Version 01 – May 2021
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