GIMA M28727NL Z Strap 3 In 1 Fixing System Instructions
- June 15, 2024
- GIMA
Table of Contents
GIMA M28727NL Z Strap 3 In 1 Fixing System
Product Information
- Product Name: Z-Strap Secure
- Model Number: 19802103 (Gima 28727)
- Manufacturer: Mizra Medical Ltd
- Manufacturer Address: 21 Hasadna Street, Industrial Park, Holon, 5881411, Israel
- Country of Origin: Israel
- Distributor: RQMIS AREU SLU
- Distributor Address: Av Diagonal 409, Barcelona 08008, Spain
- Additional Distributor: Gima S.p.A.
- Distributor Address: Via Marconi, 1 – 20060 Gessate (MI) Italy
- Email: [email protected] – [email protected]
- Website: www.gimaitaly.com
- Revision Number: M28727-M-Rev.0-09.23
Specifications
- Intended Use: Secure attachment of Foley catheter/fixation line/attachment of any size leg bag.
- Compliance: Compliant with Regulation (EU) 2017/745.
Product Usage Instructions
Step 1: Preparing the Z-Strap Secure
- Ensure that the Z-Strap Secure is clean and undamaged.
- If necessary, adjust the length of the strap according to your needs by sliding the buckle.
Step 2: Attaching the Z-Strap Secure
- Place the Z-Strap Secure around the leg, just above the knee.
- Adjust the strap to achieve a comfortable fit, ensuring it is not too tight or too loose.
- Secure the strap by fastening the buckle.
Step 3: Attaching the Foley Catheter/Fixation Line/Leg Bag
- Ensure that the Foley catheter, fixation line, or leg bag is prepared and ready for attachment.
- Position the attachment point (e.g. catheter connector) near the leg area where the Z-Strap Secure is fastened.
- Use the provided clips or hooks to secure the attachment point to the Z-Strap Secure.
Step 4: Adjusting for Comfort and Security
- Check that the attachment is secure and does not cause any discomfort or irritation.
- If necessary, make adjustments to the strap tightness or position for optimal comfort and security.
FAQ
- Q: What is the purpose of the Z-Strap Secure?
- A: The Z-Strap Secure is designed for the safe attachment of Foley catheters, fixation lines, or leg bags of any size.
- Q: Is the Z-Strap Secure compliant with regulations?
- A: Yes, the Z-Strap Secure is compliant with Regulation (EU) 2017/745.
INSTRUCTIONS FOR USE
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The Z-strap is intended for secure attachment of Foley catheter/attachment line/attachment of any size leg bag.
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Follow the instructions before using the product.
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Z-Strap Secure is an accessory from Mizra under Regulation (EU) 2017/745
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Discreetly conceals the urine bag, maintaining privacy and ensuring comfort and safety the attachment of the urine bag. Perfect for in public. One size, both urine bag and leg bag, can be washed with soap and warm water.
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Before using the product again, wash it by hand, using soap and warm water up to 60°C
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Do not reuse the device if it is broken.
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All serious accidents involving the medical device supplied by us must be reported to the manufacturer and the competent authority of the Member State where your registered office is located.
GIMA WARRANTY CONDITIONS
- The standard B2B Gima warranty of 12 months is applied
Symbol index
- Date of manufacture
- Manufacturer
- Keep away from sunlight
- Keep in a cool, dry place
- Imported by
- Caution: read instructions (warnings) carefully
- Consult instructions for use
- Non-sterile
- Lot number
- Product code
- Authorized representative in the European community
- Medical Device
- Expiration date
- Medical Device compliant with Regulation (EU) 2017/745
CONTACT
Mizra Medical ltd
- 21 Hasadna Street, Industrial Park, Holon, 5881411, Israel
- Made in Israel
- RQMIS AREU SLU, Av Diagonal 409,
- Barcelona 08008, Spain
Gima S.p.A.
- Via Marconi, 1 – 20060 Gessate (MI) Italy
- [email protected] – [email protected]
- www.gimaitaly.com