Descrizione Clinica
Medical devices - medical devices Md-shoulder italia 10fl ini2ml
MD-SHOULDER
Description
Medical device useful for improving joint mobility of the shoulder and upper limb, whose primary therapeutic treatment consists of the following functions:
1. Barrier effect.
2. Lubricant activity.
3. Mechanical support in case of ongoing drug therapy.
It is recommended to use MD-SHOULDER by qualified health personnel, at private or public health facilities for:
- improving the mobility of the shoulder and upper limb joint;
- promote muscle relaxation;
- support muscle structures;
- to relieve localized pain and that caused by movement.
Mode of use
MD-SHOULDER can be used alone or associated with other medical devices belonging to the same line, in order to ensure a personalized treatment based on the individual clinical framework.
In cases where acute pain is required, MD-SHOULDER may be associated with MD-NEURAL, MD-POLY and MD-MUSCLE (one or more of these).
In addition, in cases where a tissue matrix support therapy is required or a physiological aging slowdown action is required, MD-SHOULDER may be associated with MD-MATRIX and MD-TISSUE.
Therapeutic protocol:
1-2 treatments per week for 10 consecutive weeks.
Periarticular injectable mode of administration (the application area must be aseptic; introduce the needle near the joint to a depth of 2-4 mm).
For this use of the medical device it is recommended to use the following materials and accessories:
• Material to ensure skin axle: disposable glove, iodine based solution, alcohol solution, sterile garzes, skin spray based on ethyl chloride.
• Needles: 27 G sterile.
• Syringes: from 5 to 10 cc, according to the amount of solution to inject.
Injectable intraarticular mode of administration.
For this use of the medical device it is recommended to use the following materials and accessories:
• Material to ensure skin axle: disposable glove, iodine based solution, alcohol solution, sterile garzes, skin spray based on ethyl chloride. We recommend the application of local anesthetic on the treated skin.
• Needles: 22 G sterile.
• Syringes: from 5 to 10 cc, according to the amount of solution to inject.
- Injective intraarticular treatment of the shoulder, front part: The patient's hand is resting on the thigh, while the shoulder muscles are relaxed. Gleno-omeral articulation can be palpated with fingers between the coracoid process and the head of the humerus. As the shoulder is rotated towards the inside, you can palp the head of the humerus by turning towards the inside and perceiving the joint space as a localized instillation laterally compared to the coracoid process. Introduce a 22 G needle laterally to the coracoid process. Indirect the needle into the joint space.
- Injective intraarticular treatment of the shoulder, back part: The back of the shoulder joint can be identified by turning the patient's arm. This position can be obtained by supporting the patient's ispilateral hand on the side shoulder. You can palp the head of the humerus by placing a finger on the acromion, while the shoulder is rotated. Introduce a needle from 22 G to about 1 cm below the back tip of the acromion and direct it forward and medially.
Components
Collagen of suine origin.
Excipients: Iris, NaCl, injectable water.
Warnings
Disposable.
No hypersensitivity to MD-SHOULDER has been reported.
Contains collagen of animal origin of suine species.
Patients with proven hypersensitivity to the component or excipients must be previously subjected to injective tests in the arm and kept under observation for an hour.
Shoulder-loaded algies require differential diagnosis with chronic cervical syndrome, ischemic cardiopathy (acute/chronic, only for left shoulder), cholecystitis/colelysis (only for right shoulder), cervico-brachyalgia, muscle trigger point of trapetium.
A slight redness in the injection area can be due to the mechanical effect of the needle or a skin reaction.
The application may cause symptoms of burning/dollar in injection sites, which generally resolve within 5-10 minutes from the end of treatment.
Skin cleaning/disinfection is necessary before and after application.
Any pyogenic bacteria could produce abscess in the injection area.
Keep out of reach and sight of children.
Do not use after expiry.
Use the product immediately after opening.
Do not use in case of breakage or tampering of the seal.
After opening, the contents of the bottle must be injected immediately.
Do not use in case of packaging damage.
Conservation
Store at a temperature of 2°C and 30°C, protect against sunlight and frost.
The expiration date refers to the product in an integrated package, properly preserved.
Format
Pack of 10 2 ml sterile bottles
Cod. MD
Medical device useful for improving joint mobility of the shoulder and upper limb, whose primary therapeutic treatment consists of the following functions:
1. Barrier effect.
2. Lubricant activity.
3. Mechanical support in case of ongoing drug therapy.
It is recommended to use MD-SHOULDER by qualified health personnel, at private or public health facilities for:
- improving the mobility of the shoulder and upper limb joint;
- promote muscle relaxation;
- support muscle structures;
- to relieve localized pain and that caused by movement.
Mode of use
MD-SHOULDER can be used alone or associated with other medical devices belonging to the same line, in order to ensure a personalized treatment based on the individual clinical framework.
In cases where acute pain is required, MD-SHOULDER may be associated with MD-NEURAL, MD-POLY and MD-MUSCLE (one or more of these).
In addition, in cases where a tissue matrix support therapy is required or a physiological aging slowdown action is required, MD-SHOULDER may be associated with MD-MATRIX and MD-TISSUE.
Therapeutic protocol:
1-2 treatments per week for 10 consecutive weeks.
Periarticular injectable mode of administration (the application area must be aseptic; introduce the needle near the joint to a depth of 2-4 mm).
For this use of the medical device it is recommended to use the following materials and accessories:
• Material to ensure skin axle: disposable glove, iodine based solution, alcohol solution, sterile garzes, skin spray based on ethyl chloride.
• Needles: 27 G sterile.
• Syringes: from 5 to 10 cc, according to the amount of solution to inject.
Injectable intraarticular mode of administration.
For this use of the medical device it is recommended to use the following materials and accessories:
• Material to ensure skin axle: disposable glove, iodine based solution, alcohol solution, sterile garzes, skin spray based on ethyl chloride. We recommend the application of local anesthetic on the treated skin.
• Needles: 22 G sterile.
• Syringes: from 5 to 10 cc, according to the amount of solution to inject.
- Injective intraarticular treatment of the shoulder, front part: The patient's hand is resting on the thigh, while the shoulder muscles are relaxed. Gleno-omeral articulation can be palpated with fingers between the coracoid process and the head of the humerus. As the shoulder is rotated towards the inside, you can palp the head of the humerus by turning towards the inside and perceiving the joint space as a localized instillation laterally compared to the coracoid process. Introduce a 22 G needle laterally to the coracoid process. Indirect the needle into the joint space.
- Injective intraarticular treatment of the shoulder, back part: The back of the shoulder joint can be identified by turning the patient's arm. This position can be obtained by supporting the patient's ispilateral hand on the side shoulder. You can palp the head of the humerus by placing a finger on the acromion, while the shoulder is rotated. Introduce a needle from 22 G to about 1 cm below the back tip of the acromion and direct it forward and medially.
Components
Collagen of suine origin.
Excipients: Iris, NaCl, injectable water.
Warnings
Disposable.
No hypersensitivity to MD-SHOULDER has been reported.
Contains collagen of animal origin of suine species.
Patients with proven hypersensitivity to the component or excipients must be previously subjected to injective tests in the arm and kept under observation for an hour.
Shoulder-loaded algies require differential diagnosis with chronic cervical syndrome, ischemic cardiopathy (acute/chronic, only for left shoulder), cholecystitis/colelysis (only for right shoulder), cervico-brachyalgia, muscle trigger point of trapetium.
A slight redness in the injection area can be due to the mechanical effect of the needle or a skin reaction.
The application may cause symptoms of burning/dollar in injection sites, which generally resolve within 5-10 minutes from the end of treatment.
Skin cleaning/disinfection is necessary before and after application.
Any pyogenic bacteria could produce abscess in the injection area.
Keep out of reach and sight of children.
Do not use after expiry.
Use the product immediately after opening.
Do not use in case of breakage or tampering of the seal.
After opening, the contents of the bottle must be injected immediately.
Do not use in case of packaging damage.
Conservation
Store at a temperature of 2°C and 30°C, protect against sunlight and frost.
The expiration date refers to the product in an integrated package, properly preserved.
Format
Pack of 10 2 ml sterile bottles
Cod. MD
