Absorbent drape

SURGICAL DRAPES - OTHER

Do not re-use


Device is a biocompatible, porous, inorganic mineral matrix for use in oral and maxillofacial surgery to repair bone defects. It is derived from bovine bone through a special manufacturing process that removes organic material. Device is packaged and sterilized using gamma irradiation.

TITAN-X Syringe

DENTAL GRAFT DEVICES

15℃ ~ 25℃


K-Feile

ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE


Disposable Core Biopsy Instruments

NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER


TITAN-X Syringe

DENTAL GRAFT DEVICES

15℃ ~ 25℃


Dyna Locking Trochanteric Nail™

INTRAMEDULLARY NAILS

"STORAGE
*	Store in the packaging provided by the manufacturer until use.
*	Storage condition of Dyna Locking Trochanteric NailTM and instruments should be maintained as follows. (Temperature: 10℃~38℃)"

"CONTRAINDICATIONS
*	Contraindications of Dyna Locking Trochanteric NailTM includes:
-	Femoral fracture which contains knee joints
-	Blocked medullary cavity caused by previous fracture or tumor
-	In case the axis of femur is unusual or excessive radius’s femur
-	Used for immature skeletons
-	Foreign body sensitivity – Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
-	Conditions which tent to impair the patient`s ability or willingness to restrict activities or to follow directions during the healing period.
*	Using of Dyna Locking Trochanteric NailTM on the fracture of neck fracture which is located between the femoral head and trochanter. In case of this device, stability required for treatment of fracture of above neck middle part couldn’t be secured.
*	This device is prohibited for obvious whole body infection. In case patient appears the whole body symptoms, surgeon should act to minimize the spread the potential hematogenous until the implant inserted.
-	Fever and/or infection
-	Rapid joint destruction(broken) or absorption of bone
-	Increase of precipitation speed which couldn’t be explained as other disease.
-	Increase of white blood cell (WBC) and/or drastic movement at determine the WBC.
*	Using this device on the patients who are suffered from active infection on the genitourinary tract, lung, skin or other region is prohibited, because it could occur the spread of hematogemous. Before the surgery, lesion of infection should be treated and solved. Treatment using preventive antibiotics during the surgery, before the surgery, after the surgery could behelpful to these kinds of patients. "

"WARNINGS
*	Read this insert in detail, make the surgical technique skilled before surgery and follow all the guides.
*	This device must be used only one patient. Re-use is impossible. Re-use could influence the performance of device and threaten patient’s safety.
*	Surgeon should realize that using this device on the osteoporosis patient or improper fixation of device could increase the risk of breakage.
*	In case of using the guide wire or instruments which has long hole,
-	During the surgery, clean the long hole of instruments not to stacked the bone fragment.
-	Periodically check the position of guide wire using image amplification not to intrude to the position where is not intended it could cause infection of surrounding tissue.
-	Re-use of guide wire is not permitted.
*	Selection of proper length of neck screw is very important. If overlong size neck screw is selected and used as the slidable mode, the risk of infection can be increased because of interference between the latter part of neck screw and skin or muscle. Wedge wing of neck screw has to unfold after the prevention of neck screw rotation using nail cap. Also the neck screw has to be removed with folding the wedge wing into the inside of neck screw."

"*	Hole for cortical screw couldn’t be positioned within the 5cm of fracture site. Size of medullary cavity should be measured thoroughly by x-ray front/rear/lateral film regarding medullary cavity isthmus. (It is required that check of distal part which is not damaged to decide the size of medullary cavity.) The diameter of trochanteric nail should be similar with isthmus’s one. In other words, if the isthmus is not filled, the stress which applied trochanteric could be increased. Extremely this could cause the breakage of device. (Caution: Medullary cavity should be over reamed about 0.5~1.0mm than the trochanteric nail which is selected for insertion.) It is essential that the selection of proper length of trochanteric nail to fix the metaphysic stable using the distal locking screws. Regarding the long trochanteric nail (over 320mm), fatigue strength could be maximized when the two distal locking screws are all used. If it is impossible to insert two distal locking screws by clinical situation, insert the most proximal screw among the distal parts to get maximum strength and prevent the breakage of device. But it is prohibited that use of only one distal screw or only one distal screw which is located most distal part on communited fractures."

"*	In fact, the hole for screw fixation may reduce the device’s mechanical strength in this type device. In case of dynamization locking mode without locking screws on proximal and distal part, surgeon has to take the special caution and guide not to occur the stress concentration which causes the device breakage.
*	In case of heavy and/or very active and uncooperative patients, surgeon should pay close attention to consider the treatment procedure after surgery so the stress could be reduced which is applied on the device.
*	Application of this device to the patients who are involved hemophilia, diabetes mellitus, hypertension, surgeon should pay attention to the patients and the risk should be notified to the patients.
*	Regarding the treatment of subtrochanteric fracture, particular beforehand attention is required. In this case, reduction is more difficult that the other type’s femoral fracture and unbalanced muscle force which deliver the larger stress to the temporary internal fixation device is abnormally strong.
*	Detail guide regarding the use and limitation of this device should be supplied to the patients. If a little load is suggested or required for substantial synosteosys, the fact that bending or breakage of device is complication caused by muscle activity should be warned to the patients. The patients who couldn’t use assistant device like clutches by the disease like physical disabilities, mental illness, risky situation can be occurred during the rehabilitation procedure after the surgery. The issues regarding the load bearing is always follow the decision of surgeon, but the below factors have to be considered.: Fracture site, fracture stability, size of medullary cavity and implant size which is used, patient age, accompanied damage"

"*	Until the formation of callus at the fracture site and the callus is observed using the x-ray, patients haven’t load all the load without other assistant device. In case of small diameter’s implant used for treatment of communited fractures, it is suggested casting and load bearing accompanied assistance devices until the formation of callus is occurred. (if soft tissue is not mattered.)
*	If user finds out the breakage or fracture of device during the preparation or surgical procedure, relevant device has to be disposed.
*	Fat embolism could be degenerated by inserting the inter-medullary fixation device. This could develop into the pulmonary circulation and nervous system which could threaten patient’s life. When trochanteric nail is inserted, installation of venting for femur and tibia should be considered.
*	Do not use this device besides the indication mentioned above. (Off-label use) There are no objective materials which prove the safety and performance regarding the contraindication. Individual and organization that use the device as not indicated use could be limited under the law and regulation.
*	Do not use this device with components from other systems.
*	Only products within the shelf-life should be used. It is prohibited to reclean and resterilize the products after unpackaging.
*	Do not use the implant if the packing is damaged before use.
*	Damaged packages or products should not be used, and should be returned to CG MedTech Co., Ltd.."


Fenestrated Drape

SURGICAL DRAPES - OTHER

Do not re-use


OSTEOSYNTHESIS COMPRESSION PLATES


LAPAROSCOPIC INSTRUMENT

MINIMALLY INVASIVE SURGERY FORCEPS, SINGLE-USE


Disposable Core Biopsy Instruments


K-Feile


Dyna Locking Trochanteric Nail™

INTRAMEDULLARY NAILS


TITAN-X Block

DENTAL GRAFT DEVICES

15℃ ~ 25℃


Disposable Linear Staplers and Reloads

SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY


LAPAROSCOPIC INSTRUMENT


Disposable Linear Staplers and Reloads


TITAN-X

DENTAL GRAFT DEVICES

15℃ ~ 25℃


Sterile Acetabular Reamers

CUTTING DEVICES, SINGLE-USE - OTHER


STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES


Ti-oss®

DENTAL GRAFT DEVICES

15℃ ~ 25℃


For the in vitro quantitative determination of triglyceride (TG) content in human serum or plasma.
The significance of triglyceride determination lies in its role in aiding the diagnosis and management of hyperlipidemia. Such conditions may be primary or secondary to other diseases, including nephropathy, diabetes mellitus, and endocrine disorders. Elevated triglyceride levels are commonly observed in cases such as hyperlipidemia, nephrotic syndrome, diabetes mellitus, hepatobiliary diseases, atherosclerosis, and hypothyroidism. Decreased triglyceride levels, on the other hand, are frequently seen in scenarios like severe malnutrition, disorders of fat digestion and absorption, and hyperthyroidism.This test is a preliminary screening method and does not have the effectiveness of diagnosing diseases. It needs to be comprehensively judged in conjunction with other test results. The main methods used for triglyceride detection in clinical practice include enzymatic methods, enzyme-colorimetric methods, and endpoint methods.

Triglyceride (TG) Test Kit (GPO-PAP)

TRIGLYCERIDES

The reagent kit should be sealed and stored in a non corrosive gas environment at 2 ° C~8 ° C, away from light.


Reusable Grasping Forceps

GRASPING FORCEPS, REUSABLE - OTHER


Ti-oss® Syringe

DENTAL GRAFT DEVICES

15℃ ~ 25℃


For the in vitro quantitative determination of triglyceride (TG) content in human serum or plasma.

The significance of triglyceride determination lies in its role in aiding the diagnosis and management of hyperlipidemia. Such conditions may be primary or secondary to other diseases, including nephropathy, diabetes mellitus, and endocrine disorders. Elevated triglyceride levels are commonly observed in cases such as hyperlipidemia, nephrotic syndrome, diabetes mellitus, hepatobiliary diseases, atherosclerosis, and hypothyroidism. Decreased triglyceride levels, on the other hand, are frequently seen in scenarios like severe malnutrition, disorders of fat digestion and absorption, and hyperthyroidism.This test is a preliminary screening method and does not have the effectiveness of diagnosing diseases. It needs to be comprehensively judged in conjunction with other test results. The main methods used for triglyceride detection in clinical practice include enzymatic methods, enzyme-colorimetric methods, and endpoint methods.

Triglyceride (TG) Test Kit (GPO-PAP)

TRIGLYCERIDES


ORTHOPAEDIC SURGERY GUIDES, REUSABLE


Ti-oss® Block

DENTAL GRAFT DEVICES

15℃ ~ 25℃


CANNULATED INSTRUMENTS AND DEVICES CLEANING STYLETS


Triglyceride (TG) Test Kit (GPO-PAP)

TRIGLYCERIDES


CompactBone® B+ Syringe

DENTAL GRAFT DEVICES

15℃ ~ 25℃


ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE


Dyna Locking Trochanteric Nail™

INTRAMEDULLARY NAILS


Device is a biocompatible, porous, inorganic mineral matrix for use in oral and maxillofacial surgery to repair bone defects. It is derived from bovine bone through a special manufacturing process that removes organic material. Device is packaged and sterilized using gamma irradiation.

CompactBone® B+ Syringe

DENTAL GRAFT DEVICES

15℃ ~ 25℃


Disposable Linear Staplers and Reloads


ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER


CompactBone® B+ Block

DENTAL GRAFT DEVICES

15℃ ~ 25℃


Nonsterile natural latex probe cover, nominal 42mm width, non-lubricated without reservoir.

Dry Probe Cover

VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES

Probe covers are made of natural rubber latex which may cause allergic reactions including anaphylactic shock if the user allergic to latex. If the rubber material is sticky or brittle or torn or obviously damaged, do not use the probe cover. Probe cover intended for use by or as directed by a licensed medical practitioner during medical ultrasound imaging procedure.

If the probe cover used more than once, it increases the risk of it tearing and damage and the infection of patient. Never wash it.

If the individual container is obviously damaged, discard that probe cover and use a new one from an undamaged package

Read carefully the instructions before use.


TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS


The PainChek® Infant App is a mobile application that is downloaded from the Apple App Store and it is generally used in much the same way as any other App.
Devices running the PainChek® Infant App should be used, charged, maintained and disposed of according to the
standard instructions provided their manufacturer.
Procedural pain assessment where procedural pain is defined as short-lived acute pain associated with medical
investigations and treatments conducted for the purpose of health care.
Procedures range from minor procedures such as intravenous cannulation, venepuncture, finger and heel pricks,
immunisations, suturing and dressing changes to more invasive procedures, such as lumbar punctures, fracture
reductions and bone marrow biopsies; and may occur in a variety of settings, including but not limited to, hospitals,
day surgery centres, ambulatory care clinics, general practice, dental clinics and including in the home of infants
and their primary caregiver.
PainChek® Infant is not intended to specify or recommend any treatment or clinical interventions. The user, as a
health professional or as a layperson under the advice or prescription from a health professional, makes any clinical
decisions.

PainChek

MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES


The dental implant drills and drivers are intended for use during dental implant procedures to create an osteotomy in the alveolar bone and to assist in the insertion of the implant fixture. Drills are used in a sequential drilling protocol to achieve the desired depth and diameter, while drivers are used to deliver and place the fixture into the prepared site.

Stopper Twist Drill

DENTAL DRILLS

Body Length

Avoid direct sunlight

Store in a dry place


CompactBone® B+

DENTAL GRAFT DEVICES

15℃ ~ 25℃


Dyna Locking Trochanteric Nail™

INTRAMEDULLARY NAILS

"STORAGE
*	Store in the packaging provided by the manufacturer until use.
*	Storage condition of Dyna Locking Trochanteric NailTM and instruments should be maintained as follows. (Temperature: 10℃~38℃)"

"CONTRAINDICATIONS
*	Contraindications of Dyna Locking Trochanteric NailTM includes:
-	Femoral fracture which contains knee joints
-	Blocked medullary cavity caused by previous fracture or tumor
-	In case the axis of femur is unusual or excessive radius’s femur
-	Used for immature skeletons
-	Foreign body sensitivity – Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
-	Conditions which tent to impair the patient`s ability or willingness to restrict activities or to follow directions during the healing period.
*	Using of Dyna Locking Trochanteric NailTM on the fracture of neck fracture which is located between the femoral head and trochanter. In case of this device, stability required for treatment of fracture of above neck middle part couldn’t be secured.
*	This device is prohibited for obvious whole body infection. In case patient appears the whole body symptoms, surgeon should act to minimize the spread the potential hematogenous until the implant inserted.
-	Fever and/or infection
-	Rapid joint destruction(broken) or absorption of bone
-	Increase of precipitation speed which couldn’t be explained as other disease.
-	Increase of white blood cell (WBC) and/or drastic movement at determine the WBC.
*	Using this device on the patients who are suffered from active infection on the genitourinary tract, lung, skin or other region is prohibited, because it could occur the spread of hematogemous. Before the surgery, lesion of infection should be treated and solved. Treatment using preventive antibiotics during the surgery, before the surgery, after the surgery could behelpful to these kinds of patients. "

"WARNINGS
*	Read this insert in detail, make the surgical technique skilled before surgery and follow all the guides.
*	This device must be used only one patient. Re-use is impossible. Re-use could influence the performance of device and threaten patient’s safety.
*	Surgeon should realize that using this device on the osteoporosis patient or improper fixation of device could increase the risk of breakage.
*	In case of using the guide wire or instruments which has long hole,
-	During the surgery, clean the long hole of instruments not to stacked the bone fragment.
-	Periodically check the position of guide wire using image amplification not to intrude to the position where is not intended it could cause infection of surrounding tissue.
-	Re-use of guide wire is not permitted.
*	Selection of proper length of neck screw is very important. If overlong size neck screw is selected and used as the slidable mode, the risk of infection can be increased because of interference between the latter part of neck screw and skin or muscle. Wedge wing of neck screw has to unfold after the prevention of neck screw rotation using nail cap. Also the neck screw has to be removed with folding the wedge wing into the inside of neck screw."

"*	Hole for cortical screw couldn’t be positioned within the 5cm of fracture site. Size of medullary cavity should be measured thoroughly by x-ray front/rear/lateral film regarding medullary cavity isthmus. (It is required that check of distal part which is not damaged to decide the size of medullary cavity.) The diameter of trochanteric nail should be similar with isthmus’s one. In other words, if the isthmus is not filled, the stress which applied trochanteric could be increased. Extremely this could cause the breakage of device. (Caution: Medullary cavity should be over reamed about 0.5~1.0mm than the trochanteric nail which is selected for insertion.) It is essential that the selection of proper length of trochanteric nail to fix the metaphysic stable using the distal locking screws. Regarding the long trochanteric nail (over 320mm), fatigue strength could be maximized when the two distal locking screws are all used. If it is impossible to insert two distal locking screws by clinical situation, insert the most proximal screw among the distal parts to get maximum strength and prevent the breakage of device. But it is prohibited that use of only one distal screw or only one distal screw which is located most distal part on communited fractures."

"*	In fact, the hole for screw fixation may reduce the device’s mechanical strength in this type device. In case of dynamization locking mode without locking screws on proximal and distal part, surgeon has to take the special caution and guide not to occur the stress concentration which causes the device breakage.
*	In case of heavy and/or very active and uncooperative patients, surgeon should pay close attention to consider the treatment procedure after surgery so the stress could be reduced which is applied on the device.
*	Application of this device to the patients who are involved hemophilia, diabetes mellitus, hypertension, surgeon should pay attention to the patients and the risk should be notified to the patients.
*	Regarding the treatment of subtrochanteric fracture, particular beforehand attention is required. In this case, reduction is more difficult that the other type’s femoral fracture and unbalanced muscle force which deliver the larger stress to the temporary internal fixation device is abnormally strong.
*	Detail guide regarding the use and limitation of this device should be supplied to the patients. If a little load is suggested or required for substantial synosteosys, the fact that bending or breakage of device is complication caused by muscle activity should be warned to the patients. The patients who couldn’t use assistant device like clutches by the disease like physical disabilities, mental illness, risky situation can be occurred during the rehabilitation procedure after the surgery. The issues regarding the load bearing is always follow the decision of surgeon, but the below factors have to be considered.: Fracture site, fracture stability, size of medullary cavity and implant size which is used, patient age, accompanied damage"

"*	Until the formation of callus at the fracture site and the callus is observed using the x-ray, patients haven’t load all the load without other assistant device. In case of small diameter’s implant used for treatment of communited fractures, it is suggested casting and load bearing accompanied assistance devices until the formation of callus is occurred. (if soft tissue is not mattered.)
*	If user finds out the breakage or fracture of device during the preparation or surgical procedure, relevant device has to be disposed.
*	Fat embolism could be degenerated by inserting the inter-medullary fixation device. This could develop into the pulmonary circulation and nervous system which could threaten patient’s life. When trochanteric nail is inserted, installation of venting for femur and tibia should be considered.
*	Do not use this device besides the indication mentioned above. (Off-label use) There are no objective materials which prove the safety and performance regarding the contraindication. Individual and organization that use the device as not indicated use could be limited under the law and regulation.
*	Do not use this device with components from other systems.
*	Only products within the shelf-life should be used. It is prohibited to reclean and resterilize the products after unpackaging.
*	Do not use the implant if the packing is damaged before use.
*	Damaged packages or products should not be used, and should be returned to CG MedTech Co., Ltd.."


Device is a biocompatible, porous, inorganic mineral matrix for use in oral and maxillofacial surgery to repair bone defects. It is derived from bovine bone through a special manufacturing process that removes organic material. Device is packaged and sterilized using gamma irradiation.

CompactBone® B+

DENTAL GRAFT DEVICES

15℃ ~ 25℃


Sterile Acetabular Reamers

CUTTING DEVICES, SINGLE-USE - OTHER


PainChek® App Intended Purpose
PainChek® is intended to be used to assess and monitor pain in people who cannot verbalise such as people with dementia or communication difficulties.

Indications for Use
PainChek® is an observational pain assessment software application used to assist clinicians and carers in assessing and monitoring the levels of pain in non-verbal Residents who have been diagnosed with moderate to severe dementia and who are living in nursing homes.

The PainChek® App is a mobile application that uses facial detection and analysis technology to detect facial features indicative of the presence of pain and then combines these data with non-facial pain features inputted by the User through a series of digital checklists to confirm the presence and intensity of pain.

The PainChek® App is downloaded from the Google Play Store and it is generally used in much the same way as any other App.

PainChek


LAPAROSCOPIC INSTRUMENT

MINIMALLY INVASIVE SURGERY FORCEPS, SINGLE-USE


Natural rubber latex male condom, plain, nominal 54mm width, lubricated with silicone oil, with reservoir.

Safer Sex Pack

CONDOMS

Condoms are made of natural rubber latex which may cause allergic reactions including anaphylactic shock if the user allergic to latex. If the rubber material is sticky or brittle or obviously damaged, do not use the condom. Consult healthcare professional before use Consult a doctor or pharmacist about the compatibility of topical medicines that might come in contact with the condom.  If you are concerned the condom has been damaged during sex then seek medical assistance preferably within 24 hours, but not later than 72 hours.

Re-use of a condom may increase the risk of breakage, slippage, transmission of sexually transmitted infections including HIV

If the individual container is obviously damaged, discard that condom and use a new one from an undamaged package


Disposable Linear Staplers and Reloads

SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY


LAPAROSCOPIC INSTRUMENT


Safer Sex Pack

CONDOMS


ORTHOPAEDIC SURGERY GUIDES, REUSABLE


PainChek® App Intended Purpose
PainChek® is intended to be used to assess and monitor pain in people who cannot verbalise such as people with dementia or communication difficulties.

Indications for Use
PainChek® is an observational pain assessment software application used to assist clinicians and carers in assessing and monitoring the levels of pain in non-verbal Residents who have been diagnosed with moderate to severe dementia and who are living in nursing homes.

The PainChek® App is a mobile application that uses facial detection and analysis technology to detect facial features indicative of the presence of pain and then combines these data with non-facial pain features inputted by the User through a series of digital checklists to confirm the presence and intensity of pain.

The PainChek® App is downloaded from the Apple App Store and it is generally used in much the same way as any other App.

PainChek

MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES


ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER


Dyna Locking Trochanteric Nail™

INTRAMEDULLARY NAILS

STORAGE
*	Store in the packaging provided by the manufacturer until use.
*	Storage condition of Dyna Locking Trochanteric NailTM and instruments should be maintained as follows. (Temperature: 10℃~38℃)

CONTRAINDICATIONS
*	Contraindications of Dyna Locking Trochanteric NailTM includes:
-	Femoral fracture which contains knee joints
-	Blocked medullary cavity caused by previous fracture or tumor
-	In case the axis of femur is unusual or excessive radius’s femur
-	Used for immature skeletons
-	Foreign body sensitivity – Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
-	Conditions which tent to impair the patient`s ability or willingness to restrict activities or to follow directions during the healing period.
*	Using of Dyna Locking Trochanteric NailTM on the fracture of neck fracture which is located between the femoral head and trochanter. In case of this device, stability required for treatment of fracture of above neck middle part couldn’t be secured.
*	This device is prohibited for obvious whole body infection. In case patient appears the whole body symptoms, surgeon should act to minimize the spread the potential hematogenous until the implant inserted.
-	Fever and/or infection
-	Rapid joint destruction(broken) or absorption of bone
-	Increase of precipitation speed which couldn’t be explained as other disease.
-	Increase of white blood cell (WBC) and/or drastic movement at determine the WBC.
*	Using this device on the patients who are suffered from active infection on the genitourinary tract, lung, skin or other region is prohibited, because it could occur the spread of hematogemous. Before the surgery, lesion of infection should be treated and solved. Treatment using preventive antibiotics during the surgery, before the surgery, after the surgery could behelpful to these kinds of patients.

WARNINGS
*	Read this insert in detail, make the surgical technique skilled before surgery and follow all the guides.
*	This device must be used only one patient. Re-use is impossible. Re-use could influence the performance of device and threaten patient’s safety.
*	Surgeon should realize that using this device on the osteoporosis patient or improper fixation of device could increase the risk of breakage.
*	In case of using the guide wire or instruments which has long hole,
-	During the surgery, clean the long hole of instruments not to stacked the bone fragment.
-	Periodically check the position of guide wire using image amplification not to intrude to the position where is not intended it could cause infection of surrounding tissue.
-	Re-use of guide wire is not permitted.
*	Selection of proper length of neck screw is very important. If overlong size neck screw is selected and used as the slidable mode, the risk of infection can be increased because of interference between the latter part of neck screw and skin or muscle. Wedge wing of neck screw has to unfold after the prevention of neck screw rotation using nail cap. Also the neck screw has to be removed with folding the wedge wing into the inside of neck screw.

*	Hole for cortical screw couldn’t be positioned within the 5cm of fracture site. Size of medullary cavity should be measured thoroughly by x-ray front/rear/lateral film regarding medullary cavity isthmus. (It is required that check of distal part which is not damaged to decide the size of medullary cavity.) The diameter of trochanteric nail should be similar with isthmus’s one. In other words, if the isthmus is not filled, the stress which applied trochanteric could be increased. Extremely this could cause the breakage of device. (Caution: Medullary cavity should be over reamed about 0.5~1.0mm than the trochanteric nail which is selected for insertion.) It is essential that the selection of proper length of trochanteric nail to fix the metaphysic stable using the distal locking screws. Regarding the long trochanteric nail (over 320mm), fatigue strength could be maximized when the two distal locking screws are all used. If it is impossible to insert two distal locking screws by clinical situation, insert the most proximal screw among the distal parts to get maximum strength and prevent the breakage of device. But it is prohibited that use of only one distal screw or only one distal screw which is located most distal part on communited fractures.

*	In fact, the hole for screw fixation may reduce the device’s mechanical strength in this type device. In case of dynamization locking mode without locking screws on proximal and distal part, surgeon has to take the special caution and guide not to occur the stress concentration which causes the device breakage.
*	In case of heavy and/or very active and uncooperative patients, surgeon should pay close attention to consider the treatment procedure after surgery so the stress could be reduced which is applied on the device.
*	Application of this device to the patients who are involved hemophilia, diabetes mellitus, hypertension, surgeon should pay attention to the patients and the risk should be notified to the patients.
*	Regarding the treatment of subtrochanteric fracture, particular beforehand attention is required. In this case, reduction is more difficult that the other type’s femoral fracture and unbalanced muscle force which deliver the larger stress to the temporary internal fixation device is abnormally strong.
*	Detail guide regarding the use and limitation of this device should be supplied to the patients. If a little load is suggested or required for substantial synosteosys, the fact that bending or breakage of device is complication caused by muscle activity should be warned to the patients. The patients who couldn’t use assistant device like clutches by the disease like physical disabilities, mental illness, risky situation can be occurred during the rehabilitation procedure after the surgery. The issues regarding the load bearing is always follow the decision of surgeon, but the below factors have to be considered.: Fracture site, fracture stability, size of medullary cavity and implant size which is used, patient age, accompanied damage

*	Until the formation of callus at the fracture site and the callus is observed using the x-ray, patients haven’t load all the load without other assistant device. In case of small diameter’s implant used for treatment of communited fractures, it is suggested casting and load bearing accompanied assistance devices until the formation of callus is occurred. (if soft tissue is not mattered.)
*	If user finds out the breakage or fracture of device during the preparation or surgical procedure, relevant device has to be disposed.
*	Fat embolism could be degenerated by inserting the inter-medullary fixation device. This could develop into the pulmonary circulation and nervous system which could threaten patient’s life. When trochanteric nail is inserted, installation of venting for femur and tibia should be considered.
*	Do not use this device besides the indication mentioned above. (Off-label use) There are no objective materials which prove the safety and performance regarding the contraindication. Individual and organization that use the device as not indicated use could be limited under the law and regulation.
*	Do not use this device with components from other systems.
*	Only products within the shelf-life should be used. It is prohibited to reclean and resterilize the products after unpackaging.
*	Do not use the implant if the packing is damaged before use.
*	Damaged packages or products should not be used, and should be returned to CG MedTech Co., Ltd..


Disposable Linear Staplers and Reloads


Ice-berg∙oss™ Block

DENTAL GRAFT DEVICES

15℃ ~ 25℃


Disposable Electrosurgical Instruments

LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY SCISSORS, SINGLE-USE


Disposable Core Biopsy Instruments

NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER


Disposable Core Biopsy Instruments


Ice-berg∙oss™

DENTAL GRAFT DEVICES

15℃ ~ 25℃


Sterile Acetabular Reamers

CUTTING DEVICES, SINGLE-USE - OTHER


Device is a biocompatible, porous, inorganic mineral matrix for use in oral and maxillofacial surgery to repair bone defects. It is derived from bovine bone through a special manufacturing process that removes organic material. Device is packaged and sterilized using gamma irradiation

Ice-berg∙oss™

DENTAL GRAFT DEVICES

15℃ ~ 25℃


SEED 1dayPure moisture Bifocal (8) shows bifocal lens design and is available as an aspherical bifocal lens.
This lens material is based on a 2-HEMA compound where positive and negative ions co-exist. The lens is immersed in isotonic buffered saline with Polaxamer 407 and alginic acid. The water content is 58% and the oxygen permeability coefficient is 30.0×10−11 (cm2/sec) (mLO2/ (mL×mmHg)). The base curve is 8.8 and the index of refraction is 1.406. Borates (boric acid & sodium borate) in isotonic buffer
saline are classified as CMR 1B substances in a concentration above 0.1% weight by weight and are safe when product is used according to label instructions.

SEED 1dayPure moisture Bifocal (8)

Borates (boric acid & sodium borate)

CONTACT LENSES - HYDROGEL, DAILY SINGLE-USE

Avoid direct sunlight and avoid freezing, store at room temperature.

1. Medical conditions 　Acute and sub-acute inflammation of the anterior eye, Eye infection, Uveitis, Reduced corneal sensitivity, Dry eye or lacrimal apparatus disease to an extent that poses a problem for wearing lenses, Eyelid disorder, Allergy to an extent that affects the wearing of lenses, Other diseases which would hinder use of contact lenses. 2. Environmental conditions 　Anyone living or working in dry environments. 　Anyone living or working in an environment where dust or chemicals are likely to enter the eye. 3. Personal qualities 　Anyone who cannot follow the recommendations of their eye care practitioner, anyone who cannot use contact lenses properly, anyone who fails to attend regular check-ups, anyone who cannot follow the hygiene routine required to wear contact lenses, anyone who has an extremely nervous disposition.

4. Prohibition of reuse 　A lens cannot be reused once it has been removed from the eye. When reused, proteins and lipids contained in tears may adhere to the lens, causing the eye disorders or reuse may cause severe infections due to bacteria, mold, Acanthamoeba, etc.

WARNINGS ・ Even when used properly, wearing contact lenses may cause eye disorders such as the following, and if left untreated, these eye disorders may become serious or may result in loss of sight. To wear your contact lenses safely, be sure to read this Instructions for Use carefully and to follow the instructions of your eye care practitioner and the proper methods for handling contact lenses. 　Example for eye disorders 　　・Corneal edema ・Corneal ulcer ・Corneal infiltration ・Corneal epithelial erosion 　　・ Keratitis (including infectious keratitis) ・Conjunctivitis (including giant papillary conjunctivitis) 　　・Possibility of speeding up reduction in corneal endothelial cells 　　・Possibility of changing the shape of the cornea ・ Lenses may be damaged or become damaged. If you have inadvertently worn a lens which is damaged or otherwise faulty, or if a lens becomes damaged while you are wearing it, remove the lens immediately and consult your eye care practitioner immediately, regardless of whether you have any subjective symptoms.


Ice-berg∙oss™ Syringe

DENTAL GRAFT DEVICES

15℃ ~ 25℃


Alpha-Bio Tec™ xenobone Syringe

DENTAL GRAFT DEVICES

15℃ ~ 25℃


Snucone implant system was designed to be used in dental implant surgery. To recover the loss of masticatory function for edentulous jaw, tooth necrosis and/or Erosion of tooth, implant fixture is surgically inserted into the alveolar bone of upper or lower jaw and serves as an alternative of patient’s tooth root. Also, fixtures with diameter 5mm or more and length 6mm or less should be used on the molar region but the case of single crown is not be used. Fixtures with diameter of 3.5mm or less must be used in anterior region to prevent fracture due to excessive occlusal load.

Snucone Implant System

DENTAL IMPLANTS

Avoid direct sunlight

Store in a dry place


Benefix™ Interspinous Fixation System

IMPLANTABLE SPINAL STABILISATION OR FIXATION SYSTEMS - OTHER

"STORAGE
*	Implants and instruments should be stored in cool dry place, and shock or any impact should not be applied.
*	Storage condition of Benefix™ Interspinous Fixation System and instruments should be maintained as follows.(Temperature: 10℃~38℃)"

"WARNINGS AND PRECAUTIONS
*	Implants and instruments are provided non-sterile. Implants must be sterilized before use. Instruments must be cleaned and sterilized before use
*	Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert.
*	This system is intended to be used to augment the development of a spinal fusion by providing temporary stabilization.
*	Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use. Use of this product without a bone graft, or in cases that develop into a non-union will not be successful. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, and/or breakage of the device(s) will occur.
*	Preoperative and operating procedures including knowledge of surgical techniques, proper reduction, and proper selection and placement of the implant are important considerations in the successful utilization of this device by the surgeon. Furthermore, the proper selection and compliance of the patient will greatly affect the results.
*	Surgical Technique manual can be obtained by contacting CG MedTech Co., Ltd..
*	Patients who smoke have been shown to have an increased incidence of non-union.
*	When to use this device to diabetics, surgeon should pay attention and must inform the related risks to the patient."

"*	Products intended for single-use must not be re-used. Re-use may compromise the structural integrity of the device and/or lead to device failure which may result in patient infection or disease. Furthermore, reuse of single-use devices may create a risk of contamination e.g. due to the transmission of infectious material from one patient to another. This could result in infection or disease of the patient or user. Contaminated implants must not be reprocessed. Any CG MedTech Co., Ltd. implant that has been contaminated by blood, tissue, and/or bodily fluids/matter should never be used again and should be handled according to hospital protocol. Even though they may appear undamaged, the implants may have small defects and internal stress patterns that may cause material fatigue.
*	Only products within the shelf-life shall be used, and it is prohibited to re-clean and re-sterilize if the product packaging is open.
*	Do not use the implant if the packaging is damaged before use."

"CONTRAINDICATIONS
Contraindications for BenefixTM Interspinous Fixation System are similar to those of other systems of similar design, and include, but are not limited to:
*	Patients with probable intolerance to the materials used in the manufacture of this device.
*	Patients with infection, fever, tumors, elevated white blood count, morbid obesity, pregnancy, mental illness and other medical conditions which would prohibit beneficial surgical outcome.
*	Patients resistant to following post-operative restrictions on movement, especially in athletic and occupational activities.
*	Use with components from other systems.
*	Grossly distorted anatomy caused by congenital abnormalities.
*	Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery.
*	Rapid joint disease, bone absorption, osteopenia. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation.
*	Any case where the implant components selected for use would be too large or too small to achieve a successful result.
*	Any patient having inadequate tissue coverage over the operative site or inadequate bone shape or quality.
*	Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
*	Any case not described in the indications for use.
*	Incompetent or missing posterior arch (e.g., laminectomy, pars defect, severe osteoporosis).
*	Reuse or multiple uses.
*	Prior fusion at the level(s) to be treated.
*	Metal allergy."


ORTHOPAEDIC SURGERY GUIDES, REUSABLE


Benefix™ Interspinous Fixation System


ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES


EMG Nerve Stimulator System

Neurovision Medical Products Inc.

ELECTROMYOGRAPHS


ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE


BITS FOR NEUROSURGERY DRILLS, REUSABLE


The Univfy PreIVF Report is a patient counseling support tool, not a diagnostic or therapeutic tool. It is designed to be used by physicians or healthcare providers when recommending assisted reproductive technology (ART) as a treatment option to infertile/subfertile patients needing medical treatment to conceive. The Univfy PreIVF Report does not prescribe any treatment. It merely provides the personalized probability of treatment success based on that center's past clinical data and outcomes and the health proﬁle of the patient +/- her partner that is known at the time of the counseling (i.e. prior to ART treatment).

MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES


ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER


Staxi

PUSH WHEELCHAIRS


Illuminated Dental Isolation System

Isolite, i3

SALIVA ASPIRATORS AND SALIVA ABSORBENTS

Room Temperature


IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC

45.00 °C


45.00 °C


Illuminated Dental Isolation System

Isolite, i3, ITA

SALIVA ASPIRATORS AND SALIVA ABSORBENTS

Room Temperature


Das Medizinprodukt ist zur Kompressionstherapie von venösen Erkrankungen und Schwellungen der unteren Gliedmaßen unterschiedlichen Ursprungs bestimmt.

Wyrób medyczny jest przeznaczony do terapii kompresyjnej w leczeniu chorób żylnych i różnego pochodzenia obrzęków kończyn dolnych.

Zdravotnický prostředek určený ke kompresivní terapii žilních onemocnění a otoků různého původu dolních končetin.

Ce dispositif médical est destiné à la thérapie par compression des troubles circulatoires et des différents types d’oedèmes de la jambe.

Bu medikal ürün, dolaşım bozukluklarının ve bacaktaki çeşitli ödem türlerinin kompresyon yoluyla tedavi edilmesi amacıyla tasarlanmıştır.

The medical device intended for the compression therapy of venous conditions and swelling of the legs of various origin.

Zdravotnícka pomôcka určená na kompresívnu terapiu žilových ochorení a opuchov rôzneho pôvodu dolných končatín.

Avicenum PHLEBO 70 punčochy stehenní

Avicenum PHLEBO 70 thigh-high stockings

Avicenum PHLEBO 70 pończochy

Avicenum PHLEBO 70 pančuchy stehenné

Avicenum PHLEBO 70 bas cuisse

Avicenum PHLEBO 70 Schenkelstrümpfe

Avicenum PHLEBO 70 Diz üstü çorap

COMPRESSION STOCKINGS

S

lace, closed toe

• zdravotní punčochy lze prát v pračce (maximální teplota praní 30°C, mírný postup), nejlépe v ochranném obalu (prací sáček) • nepoužívejte aviváž • sušte ve vodorovné poloze mimo přímý zdroj tepla (radiátor, slunce) • zdravotnické prostředky nežehlete • maximální možný počet pracích cyklů je 120 • skladujte v suchu a temnu, nejlépe v originálním obalu • do zdravotnických prostředků nijak mechanicky nezasahujte, neopravujte místa poškozená používáním, nenastřihávejte okraje • zdravotnické prostředky nesmí přijít do styku s organickými rozpouštědly, bělícími přípravky

• Medical socks can be washed in a washing machine (maximum wash temperature 30°C, gentle cycle), preferably in a protective cover (wash bag) • Do not use fabric softener • Lay flat to dry away from sources of direct heat (radiator, sunlight) • Do not iron medical devices • Maximum number of washing cycles is 120 • Store in a dark, dry place in the original packaging if possible • Do not make mechanical changes to the medical device, do not repair areas damaged by use, do not trim the edges • Keep the medical device away from organic solvents and bleaching agents

• wyroby medyczne można prać w pralce (maksymalna temperatura prania 30°C, program delikatny), najlepiej w opakowaniu ochronnym (worek do prania) • nie używać płynu do płukania tkanin • suszyć w pozycji poziomej nie wystawiając na bezpośrednie działanie źródła ciepła (grzejnik, słońce) • nie prasować wyrobów medycznych • maksymalna liczba cykli prania to 120 • przechowywać w suchym i ciemnym miejscu, najlepiej w oryginalnym opakowaniu • nie ingerować mechanicznie w wyroby medyczne, nie naprawiać miejsc uszkodzonych w wyniku użytkowania, nie przycinać krawędzi • wyroby medyczne nie mogą mieć kontaktu z rozpuszczalnikami organicznymi, środkami wybielającymi

• zdravotné pančuchy sa môžu prať v práčke (maximálna teplota prania 30 °C, šetrný cyklus), najlepšie v ochrannom obale (vrecko na pranie) • nepoužívajte aviváž • sušte vo vodorovnej polohe mimo priameho zdroja tepla (radiátor, slnko) • zdravotnícke pomôcky nežehlite • maximálny možný počet pracích cyklov je 120 • skladujte v suchu a v tme, najlepšie v originálnom obale • do zdravotníckych pomôcok nijako mechanicky nezasahujte, neopravujte miesta poškodené používaním, nenastrihávajte okraje • zdravotnícke pomôcky nesmú prísť do styku s organickými rozpúšťadlami, bieliacimi prípravkami

• Les chaussettes médicales peuvent être lavées en machine (température maximale de lavage 30°C, cycle délicat), de préférence dans une housse de protection (sac de lavage) • Ne pas utiliser d’assouplissants • Sécher à plat, à l’abri de toute source de chaleur directe (radiateur, soleil) • Ne pas repasser les dispositifs médicaux • Le nombre maximum de cycles de lavage est de 120 • Conservez le produit dans un endroit sombre et sec, si possible dans l’emballage d’origine • Ne pas apporter de modifications mécaniques au dispositif médical, ne pas réparer les zones endommagées par l’utilisation, ne pas découper les bords • Conservez le dispositif médical à l’écart des solvants organiques et des agents de blanchiment

• die medizinischen Socken können in der Waschmaschine gewaschen werden (maximale Waschtemperatur 30 °C, Schonwaschgang), vorzugsweise in einer Schutzhülle (Waschbeutel) • keinen Weichspüler verwenden • in waagerechter Lage ohne direkten Kontakt zu Wärmequellen (Heizkörper, Sonne) trocknen • Medizinprodukte nicht bügeln • maximal 120 Waschzyklen möglich • an einem trockenen und dunklen Ort lagern, vorzugsweise in der Originalverpackung • keine mechanischen Eingriffe an Medizinprodukten vornehmen, keine durch den Gebrauch beschädigten Stellen reparieren, Kanten nicht anschneiden • die Medizinprodukte dürfen nicht in Kontakt mit organischen Lösungsmitteln oder Bleichmitteln kommen

• Medikal çoraplar çamaşır makinesinde (maksimum yıkama sıcaklığı 30°C, hassas yıkama), koruyucu bir kılıf (yıkama torbası) kullanarak yıkanabilir • Yumuşatıcı kullanmayınız • Kuruması için doğrudan ısı kaynağından (radyatör, doğrudan güneş ışığı) uzakta düz bir zemine serin • Medikal ürünleri ütülemeyin • Maksimum 120 defa yıkanabilir • Mümkünse orijinal paketinde karanlık ve kuru bir yerde saklayınız • Medikal ürün üzerinde mekanik değişiklikler yapmayın, kullanımdan dolayı hasar gören bölgeleri onarmayın ve kenarlarını kesmeyin • Medikal ürünü organik çözücülerden ve ağartıcı maddelerden uzak tutun

Kdy nepoužívat: Zdravotnický prostředek ihned přestaňte používat pokud: • se objeví známky mechanického poškození (kompresivní punčochový zdravotnický prostředek vyměňte za nový) • pozorujete zhoršení zdravotního stavu, které by mohlo mít souvislost s používáním kompresivního zdravotnického prostředku - v takovém případě se poraďte se svým ošetřujícím lékařem Kontraindikace: • akutní mokvající kožní projevy • akutní končetinová ischemie • kritická končetinová ischemie • dekompenzovaná kardiální insuficience • phlegmazia coerulea dolens, phlegmazia alba dolens • přecitlivělost na použité materiály • poruchy citlivosti končetin (např. periferní neuropatie při diabetes mellitus)

When not to use: Stop using the product immediately if any of the following conditions apply: • There are signs of mechanical damage – replace with new compression medical stockings • You notice a deterioration in your health that may be associated with the use of the compression medical device – consult your doctor in such case Contraindications: • Acute weeping skin manifestations • Acute limb ischaemia • Critical limb ischaemia • Decompensated cardiac insufficiency • Phlegmasia cerulea dolens, phlegmasia alba dolens • Hypersensitivity to materials used • Limb numbness disorders (e.g. peripheral neuropathy in diabetes mellitus)

Kiedy nie używać: Należy natychmiast zaprzestać użytkowania wyrobu medycznego gdy: • pojawią się oznaki mechanicznego uszkodzenia (kompresyjny medyczny wyrób pończoszniczy należy wymienić na nowy) • zauważysz niepokojącą zmianę stanu zdrowia, która może wynikać z używania kompresyjnego wyrobu medycznego – w takim wypadku skontaktuj się ze swoim lekarzem prowadzącym Przeciwwskazania: • uciążliwe sączące się uszkodzenia skóry • ostre niedokrwienie kończyn • krytyczne niedokrwienie kończyn • zdekompensowana niewydolność serca • phlegmazia coerulea dolens, phlegmazia alba dolens • nadwrażliwość na użyte materiały • zaburzenia tkliwości kończyn (np. neuropatia peryferyjna przy diabetes mellitus)

Kedy nepoužívať: Zdravotnícku pomôcku ihneď prestaňte používať, ak: • sa na nej objavia známky mechanického poškodenia (kompresívnu zdravotnícku pomôcku vymeňte za novú) • pozorujete zhoršenie zdravotného stavu, ktoré by mohlo mať súvislosť s používaním kompresívnej zdravotníckej pomôcky – v takom prípade sa poraďte so svojím ošetrujúcim lekárom Kontraindikácie: • akútne mokvajúce kožné prejavy • akútna končatinová ischémia • kritická končatinová ischémia • dekompenzovaná srdcová nedostatočnosť • phlegmazia coerulea dolens, phlegmazia albumu dolens • precitlivenosť na použité materiály • poruchy citlivosti končatín (napr. periférna neuropatia pri diabetes mellitus)

Quand ne pas l’utiliser : Cessez immédiatement d’utiliser le produit si l’une des conditions suivantes s’applique : • Il y a des signes de dommages mécaniques. Remplacez par des nouveaux bas de compression médicale • Vous constatez une détérioration de votre état de santé qui pourrait être associée à l’utilisation du dispositif médical - consultez votre médecin Contre-indications : • Manifestations cutanées aiguës et suintantes • Ischémie aiguë des membres • Ischémie critique des membres • Insuffisance cardiaque décompensée • Phlegmasia cerulea dolens, phlegmasia alba dolens • Hypersensibilité aux matériaux utilisés • Engourdissement des membres (par exemple, neuropathie périphérique en cas de diabète sucré)

Nicht verwenden: Brechen Sie die Anwendung des Medizinproduktes sofort ab, wenn: • Anzeichen einer mechanischen Beschädigung auftreten (ersetzen Sie den medizinischen Kompressionsstrumpf durch einen neuen) • Sie eine Verschlechterung Ihres Gesundheitszustands beobachten, die mit der Anwendung des medizinischen Kompressionsstrumpfs im Zusammenhang stehen könnte – beraten Sie sich in einem solchen Fall mit Ihrem behandelnden Arzt Kontraindikation: • akute nässende Hautausschläge • akute Ischämie der Gliedmaßen • kritische Ischämie der Gliedmaßen • dekompensierte kardiale Insuffizienz • Phlegmazia coerulea dolens, Phlegmazia alba dolens • Überempfindlichkeit gegenüber den verwendeten Materialien • Störungen der Empfindlichkeit der Gliedmaßen (z. B. periphere Neuropathie bei Diabetes mellitus)

Ne zaman kullanılmamalıdır: Aşağıdaki koşullardan herhangi biri geçerliyse ürünü kullanmayı derhal bırakın: • Mekanik hasar belirtileri varsa yeni kompresyon çorapları ile değiştirin • Sağlığınızda medikal kompresyon ürünü kullanımıyla ilişkili olabilecek bir bozulma fark ederseniz, böyle bir durumda doktorunuza danışın Kontrendikasyonlar: • Akut sızıntılı deri bulguları • Akut uzuv iskemisi • Kritik uzuv iskemisi • Dekompanse kalp yetmezliği • Phlegmasia cerulea dolens, phlegmasia alba dolens • Kullanılan materyallere karşı aşırı hassasiyet • Uzuv uyuşma bozuklukları (örn. diabetes mellitusta periferik nöropati)


Das Medizinprodukt ist zur Kompressionstherapie von venösen Erkrankungen und Schwellungen der unteren Gliedmaßen unterschiedlichen Ursprungs bestimmt.

Wyrób medyczny jest przeznaczony do terapii kompresyjnej w leczeniu chorób żylnych i różnego pochodzenia obrzęków kończyn dolnych.

Zdravotnický prostředek určený ke kompresivní terapii žilních onemocnění a otoků různého původu dolních končetin.

Ce dispositif médical est destiné à la thérapie par compression des troubles circulatoires et des différents types d’oedèmes de la jambe.

Bu medikal ürün, dolaşım bozukluklarının ve bacaktaki çeşitli ödem türlerinin kompresyon yoluyla tedavi edilmesi amacıyla tasarlanmıştır.

The medical device intended for the compression therapy of venous conditions and swelling of the legs of various origin.

Zdravotnícka pomôcka určená na kompresívnu terapiu žilových ochorení a opuchov rôzneho pôvodu dolných končatín.

Avicenum PHLEBO 70 punčochy stehenní

Avicenum PHLEBO 70 thigh-high stockings

Avicenum PHLEBO 70 pończochy

Avicenum PHLEBO 70 pančuchy stehenné

Avicenum PHLEBO 70 bas cuisse

Avicenum PHLEBO 70 Schenkelstrümpfe

Avicenum PHLEBO 70 Diz üstü çorap

COMPRESSION STOCKINGS

S

lace,closed toe

• zdravotní punčochy lze prát v pračce (maximální teplota praní 30°C, mírný postup), nejlépe v ochranném obalu (prací sáček) • nepoužívejte aviváž • sušte ve vodorovné poloze mimo přímý zdroj tepla (radiátor, slunce) • zdravotnické prostředky nežehlete • maximální možný počet pracích cyklů je 120 • skladujte v suchu a temnu, nejlépe v originálním obalu • do zdravotnických prostředků nijak mechanicky nezasahujte, neopravujte místa poškozená používáním, nenastřihávejte okraje • zdravotnické prostředky nesmí přijít do styku s organickými rozpouštědly, bělícími přípravky

• Medical socks can be washed in a washing machine (maximum wash temperature 30°C, gentle cycle), preferably in a protective cover (wash bag) • Do not use fabric softener • Lay flat to dry away from sources of direct heat (radiator, sunlight) • Do not iron medical devices • Maximum number of washing cycles is 120 • Store in a dark, dry place in the original packaging if possible • Do not make mechanical changes to the medical device, do not repair areas damaged by use, do not trim the edges • Keep the medical device away from organic solvents and bleaching agents

• wyroby medyczne można prać w pralce (maksymalna temperatura prania 30°C, program delikatny), najlepiej w opakowaniu ochronnym (worek do prania) • nie używać płynu do płukania tkanin • suszyć w pozycji poziomej nie wystawiając na bezpośrednie działanie źródła ciepła (grzejnik, słońce) • nie prasować wyrobów medycznych • maksymalna liczba cykli prania to 120 • przechowywać w suchym i ciemnym miejscu, najlepiej w oryginalnym opakowaniu • nie ingerować mechanicznie w wyroby medyczne, nie naprawiać miejsc uszkodzonych w wyniku użytkowania, nie przycinać krawędzi • wyroby medyczne nie mogą mieć kontaktu z rozpuszczalnikami organicznymi, środkami wybielającymi

• zdravotné pančuchy sa môžu prať v práčke (maximálna teplota prania 30 °C, šetrný cyklus), najlepšie v ochrannom obale (vrecko na pranie) • nepoužívajte aviváž • sušte vo vodorovnej polohe mimo priameho zdroja tepla (radiátor, slnko) • zdravotnícke pomôcky nežehlite • maximálny možný počet pracích cyklov je 120 • skladujte v suchu a v tme, najlepšie v originálnom obale • do zdravotníckych pomôcok nijako mechanicky nezasahujte, neopravujte miesta poškodené používaním, nenastrihávajte okraje • zdravotnícke pomôcky nesmú prísť do styku s organickými rozpúšťadlami, bieliacimi prípravkami

• Les chaussettes médicales peuvent être lavées en machine (température maximale de lavage 30°C, cycle délicat), de préférence dans une housse de protection (sac de lavage) • Ne pas utiliser d’assouplissants • Sécher à plat, à l’abri de toute source de chaleur directe (radiateur, soleil) • Ne pas repasser les dispositifs médicaux • Le nombre maximum de cycles de lavage est de 120 • Conservez le produit dans un endroit sombre et sec, si possible dans l’emballage d’origine • Ne pas apporter de modifications mécaniques au dispositif médical, ne pas réparer les zones endommagées par l’utilisation, ne pas découper les bords • Conservez le dispositif médical à l’écart des solvants organiques et des agents de blanchiment

• die medizinischen Socken können in der Waschmaschine gewaschen werden (maximale Waschtemperatur 30 °C, Schonwaschgang), vorzugsweise in einer Schutzhülle (Waschbeutel) • keinen Weichspüler verwenden • in waagerechter Lage ohne direkten Kontakt zu Wärmequellen (Heizkörper, Sonne) trocknen • Medizinprodukte nicht bügeln • maximal 120 Waschzyklen möglich • an einem trockenen und dunklen Ort lagern, vorzugsweise in der Originalverpackung • keine mechanischen Eingriffe an Medizinprodukten vornehmen, keine durch den Gebrauch beschädigten Stellen reparieren, Kanten nicht anschneiden • die Medizinprodukte dürfen nicht in Kontakt mit organischen Lösungsmitteln oder Bleichmitteln kommen

• Medikal çoraplar çamaşır makinesinde (maksimum yıkama sıcaklığı 30°C, hassas yıkama), koruyucu bir kılıf (yıkama torbası) kullanarak yıkanabilir • Yumuşatıcı kullanmayınız • Kuruması için doğrudan ısı kaynağından (radyatör, doğrudan güneş ışığı) uzakta düz bir zemine serin • Medikal ürünleri ütülemeyin • Maksimum 120 defa yıkanabilir • Mümkünse orijinal paketinde karanlık ve kuru bir yerde saklayınız • Medikal ürün üzerinde mekanik değişiklikler yapmayın, kullanımdan dolayı hasar gören bölgeleri onarmayın ve kenarlarını kesmeyin • Medikal ürünü organik çözücülerden ve ağartıcı maddelerden uzak tutun

Kdy nepoužívat: Zdravotnický prostředek ihned přestaňte používat pokud: • se objeví známky mechanického poškození (kompresivní punčochový zdravotnický prostředek vyměňte za nový) • pozorujete zhoršení zdravotního stavu, které by mohlo mít souvislost s používáním kompresivního zdravotnického prostředku - v takovém případě se poraďte se svým ošetřujícím lékařem Kontraindikace: • akutní mokvající kožní projevy • akutní končetinová ischemie • kritická končetinová ischemie • dekompenzovaná kardiální insuficience • phlegmazia coerulea dolens, phlegmazia alba dolens • přecitlivělost na použité materiály • poruchy citlivosti končetin (např. periferní neuropatie při diabetes mellitus)

When not to use: Stop using the product immediately if any of the following conditions apply: • There are signs of mechanical damage – replace with new compression medical stockings • You notice a deterioration in your health that may be associated with the use of the compression medical device – consult your doctor in such case Contraindications: • Acute weeping skin manifestations • Acute limb ischaemia • Critical limb ischaemia • Decompensated cardiac insufficiency • Phlegmasia cerulea dolens, phlegmasia alba dolens • Hypersensitivity to materials used • Limb numbness disorders (e.g. peripheral neuropathy in diabetes mellitus)

Kiedy nie używać: Należy natychmiast zaprzestać użytkowania wyrobu medycznego gdy: • pojawią się oznaki mechanicznego uszkodzenia (kompresyjny medyczny wyrób pończoszniczy należy wymienić na nowy) • zauważysz niepokojącą zmianę stanu zdrowia, która może wynikać z używania kompresyjnego wyrobu medycznego – w takim wypadku skontaktuj się ze swoim lekarzem prowadzącym Przeciwwskazania: • uciążliwe sączące się uszkodzenia skóry • ostre niedokrwienie kończyn • krytyczne niedokrwienie kończyn • zdekompensowana niewydolność serca • phlegmazia coerulea dolens, phlegmazia alba dolens • nadwrażliwość na użyte materiały • zaburzenia tkliwości kończyn (np. neuropatia peryferyjna przy diabetes mellitus)

Kedy nepoužívať: Zdravotnícku pomôcku ihneď prestaňte používať, ak: • sa na nej objavia známky mechanického poškodenia (kompresívnu zdravotnícku pomôcku vymeňte za novú) • pozorujete zhoršenie zdravotného stavu, ktoré by mohlo mať súvislosť s používaním kompresívnej zdravotníckej pomôcky – v takom prípade sa poraďte so svojím ošetrujúcim lekárom Kontraindikácie: • akútne mokvajúce kožné prejavy • akútna končatinová ischémia • kritická končatinová ischémia • dekompenzovaná srdcová nedostatočnosť • phlegmazia coerulea dolens, phlegmazia albumu dolens • precitlivenosť na použité materiály • poruchy citlivosti končatín (napr. periférna neuropatia pri diabetes mellitus)

Quand ne pas l’utiliser : Cessez immédiatement d’utiliser le produit si l’une des conditions suivantes s’applique : • Il y a des signes de dommages mécaniques. Remplacez par des nouveaux bas de compression médicale • Vous constatez une détérioration de votre état de santé qui pourrait être associée à l’utilisation du dispositif médical - consultez votre médecin Contre-indications : • Manifestations cutanées aiguës et suintantes • Ischémie aiguë des membres • Ischémie critique des membres • Insuffisance cardiaque décompensée • Phlegmasia cerulea dolens, phlegmasia alba dolens • Hypersensibilité aux matériaux utilisés • Engourdissement des membres (par exemple, neuropathie périphérique en cas de diabète sucré)

Nicht verwenden: Brechen Sie die Anwendung des Medizinproduktes sofort ab, wenn: • Anzeichen einer mechanischen Beschädigung auftreten (ersetzen Sie den medizinischen Kompressionsstrumpf durch einen neuen) • Sie eine Verschlechterung Ihres Gesundheitszustands beobachten, die mit der Anwendung des medizinischen Kompressionsstrumpfs im Zusammenhang stehen könnte – beraten Sie sich in einem solchen Fall mit Ihrem behandelnden Arzt Kontraindikation: • akute nässende Hautausschläge • akute Ischämie der Gliedmaßen • kritische Ischämie der Gliedmaßen • dekompensierte kardiale Insuffizienz • Phlegmazia coerulea dolens, Phlegmazia alba dolens • Überempfindlichkeit gegenüber den verwendeten Materialien • Störungen der Empfindlichkeit der Gliedmaßen (z. B. periphere Neuropathie bei Diabetes mellitus)

Ne zaman kullanılmamalıdır: Aşağıdaki koşullardan herhangi biri geçerliyse ürünü kullanmayı derhal bırakın: • Mekanik hasar belirtileri varsa yeni kompresyon çorapları ile değiştirin • Sağlığınızda medikal kompresyon ürünü kullanımıyla ilişkili olabilecek bir bozulma fark ederseniz, böyle bir durumda doktorunuza danışın Kontrendikasyonlar: • Akut sızıntılı deri bulguları • Akut uzuv iskemisi • Kritik uzuv iskemisi • Dekompanse kalp yetmezliği • Phlegmasia cerulea dolens, phlegmasia alba dolens • Kullanılan materyallere karşı aşırı hassasiyet • Uzuv uyuşma bozuklukları (örn. diabetes mellitusta periferik nöropati)


Krzesełko Prysznicowe Uchylne KPU-2 PP INOX MAT

WASHING, BATHING AND SHOWERING DEVICES - OTHER


Krzesełko Prysznicowe Uchylne KPU-2 PP INOX


Krzesełko Prysznicowe Uchylne KPU-2 PP 9005


Krzesełko Prysznicowe Uchylne KPU-2 PP


Krzesełko Prysznicowe Uchylne KPU PP INOX MAT


iFuse TORQ TNT Navigation Instrument Set

ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE


Krzesełko Prysznicowe Uchylne KPU PP INOX


iFuse TORQ TNT Instrument Set


Krzesełko Prysznicowe Uchylne KPU PP 9005


Krzesełko Prysznicowe Uchylne KPU PP


Vaporizer

Serenity S Vaporizer PIRAMAL SEV Piramal-Fill DA

Lead (Pb)

Boron Trioxide (B2O3)

ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES

57 to 106 kPa

-25ºC to +40ºC; Up to 95% RH, non-condensing / +40ºC to +50ºC; Up to 85% RH, non-condensing / +50ºC to +60ºC; Up to 55% RH, non-condensing

-25ºC to +60ºC (Protect the vaporizer packaging from condensation).


Vaporizer

Serenity S Vaporizer PIRAMAL SEV Piramal-Fill DE, FR, IT, ES, EN CEI 23-50 Power Cord

Lead (Pb)

Boron Trioxide (B2O3)

57 to 106 kPa


Vaporizer

Serenity S Vaporizer PIRAMAL SEV Piramal-Fill RO, ES, PT, EL, ET CEE 7/7 Power Cord

Lead (Pb)

Boron Trioxide (B2O3)

57 to 106 kPa


Vaporizer

Serenity S Vaporizer PIRAMAL SEV Piramal-Fill KK, LV, LT, RU, UK CEE 7/7 Power Cord

Lead (Pb)

Boron Trioxide (B2O3)

57 to 106 kPa


Vaporizer

Serenity S Vaporizer PIRAMAL SEV Piramal-Fill BG, HR, CS, SK, SR CEE 7/7 Power Cord

Lead (Pb)

Boron Trioxide (B2O3)

57 to 106 kPa


Vaporizer

Serenity S Vaporizer PIRAMAL SEV Piramal-Fill FI, HU, NO, PL, SV CEE 7/7 Power Cord

Lead (Pb)

Boron Trioxide (B2O3)

57 to 106 kPa


Das Medizinprodukt ist zur Kompressionstherapie von venösen Erkrankungen und Schwellungen der unteren Gliedmaßen unterschiedlichen Ursprungs bestimmt.

Wyrób medyczny jest przeznaczony do terapii kompresyjnej w leczeniu chorób żylnych i różnego pochodzenia obrzęków kończyn dolnych.

Zdravotnický prostředek určený ke kompresivní terapii žilních onemocnění a otoků různého původu dolních končetin.

Ce dispositif médical est destiné à la thérapie par compression des troubles circulatoires et des différents types d’oedèmes de la jambe.

Bu medikal ürün, dolaşım bozukluklarının ve bacaktaki çeşitli ödem türlerinin kompresyon yoluyla tedavi edilmesi amacıyla tasarlanmıştır.

The medical device intended for the compression therapy of venous conditions and swelling of the legs of various origin.

Zdravotnícka pomôcka určená na kompresívnu terapiu žilových ochorení a opuchov rôzneho pôvodu dolných končatín.

Avicenum PHLEBO 70 punčochové kalhoty

Avicenum PHLEBO 70 tights

Avicenum PHLEBO 70 rajstopy

Avicenum PHLEBO 70 pančuchové nohavice

Avicenum PHLEBO 70 collants

Avicenum PHLEBO 70 Strumpfhose

Avicenum PHLEBO 70 Külotlu çorap

COMPRESSION STOCKINGS

XL+

closed toe, large gusset

• zdravotní punčochy lze prát v pračce (maximální teplota praní 30°C, mírný postup), nejlépe v ochranném obalu (prací sáček) • nepoužívejte aviváž • sušte ve vodorovné poloze mimo přímý zdroj tepla (radiátor, slunce) • zdravotnické prostředky nežehlete • maximální možný počet pracích cyklů je 120 • skladujte v suchu a temnu, nejlépe v originálním obalu • do zdravotnických prostředků nijak mechanicky nezasahujte, neopravujte místa poškozená používáním, nenastřihávejte okraje • zdravotnické prostředky nesmí přijít do styku s organickými rozpouštědly, bělícími přípravky

• Medical socks can be washed in a washing machine (maximum wash temperature 30°C, gentle cycle), preferably in a protective cover (wash bag) • Do not use fabric softener • Lay flat to dry away from sources of direct heat (radiator, sunlight) • Do not iron medical devices • Maximum number of washing cycles is 120 • Store in a dark, dry place in the original packaging if possible • Do not make mechanical changes to the medical device, do not repair areas damaged by use, do not trim the edges • Keep the medical device away from organic solvents and bleaching agents

• wyroby medyczne można prać w pralce (maksymalna temperatura prania 30°C, program delikatny), najlepiej w opakowaniu ochronnym (worek do prania) • nie używać płynu do płukania tkanin • suszyć w pozycji poziomej nie wystawiając na bezpośrednie działanie źródła ciepła (grzejnik, słońce) • nie prasować wyrobów medycznych • maksymalna liczba cykli prania to 120 • przechowywać w suchym i ciemnym miejscu, najlepiej w oryginalnym opakowaniu • nie ingerować mechanicznie w wyroby medyczne, nie naprawiać miejsc uszkodzonych w wyniku użytkowania, nie przycinać krawędzi • wyroby medyczne nie mogą mieć kontaktu z rozpuszczalnikami organicznymi, środkami wybielającymi

• zdravotné pančuchy sa môžu prať v práčke (maximálna teplota prania 30 °C, šetrný cyklus), najlepšie v ochrannom obale (vrecko na pranie) • nepoužívajte aviváž • sušte vo vodorovnej polohe mimo priameho zdroja tepla (radiátor, slnko) • zdravotnícke pomôcky nežehlite • maximálny možný počet pracích cyklov je 120 • skladujte v suchu a v tme, najlepšie v originálnom obale • do zdravotníckych pomôcok nijako mechanicky nezasahujte, neopravujte miesta poškodené používaním, nenastrihávajte okraje • zdravotnícke pomôcky nesmú prísť do styku s organickými rozpúšťadlami, bieliacimi prípravkami

• Les chaussettes médicales peuvent être lavées en machine (température maximale de lavage 30°C, cycle délicat), de préférence dans une housse de protection (sac de lavage) • Ne pas utiliser d’assouplissants • Sécher à plat, à l’abri de toute source de chaleur directe (radiateur, soleil) • Ne pas repasser les dispositifs médicaux • Le nombre maximum de cycles de lavage est de 120 • Conservez le produit dans un endroit sombre et sec, si possible dans l’emballage d’origine • Ne pas apporter de modifications mécaniques au dispositif médical, ne pas réparer les zones endommagées par l’utilisation, ne pas découper les bords • Conservez le dispositif médical à l’écart des solvants organiques et des agents de blanchiment

• die medizinischen Socken können in der Waschmaschine gewaschen werden (maximale Waschtemperatur 30 °C, Schonwaschgang), vorzugsweise in einer Schutzhülle (Waschbeutel) • keinen Weichspüler verwenden • in waagerechter Lage ohne direkten Kontakt zu Wärmequellen (Heizkörper, Sonne) trocknen • Medizinprodukte nicht bügeln • maximal 120 Waschzyklen möglich • an einem trockenen und dunklen Ort lagern, vorzugsweise in der Originalverpackung • keine mechanischen Eingriffe an Medizinprodukten vornehmen, keine durch den Gebrauch beschädigten Stellen reparieren, Kanten nicht anschneiden • die Medizinprodukte dürfen nicht in Kontakt mit organischen Lösungsmitteln oder Bleichmitteln kommen

• Medikal çoraplar çamaşır makinesinde (maksimum yıkama sıcaklığı 30°C, hassas yıkama), koruyucu bir kılıf (yıkama torbası) kullanarak yıkanabilir • Yumuşatıcı kullanmayınız • Kuruması için doğrudan ısı kaynağından (radyatör, doğrudan güneş ışığı) uzakta düz bir zemine serin • Medikal ürünleri ütülemeyin • Maksimum 120 defa yıkanabilir • Mümkünse orijinal paketinde karanlık ve kuru bir yerde saklayınız • Medikal ürün üzerinde mekanik değişiklikler yapmayın, kullanımdan dolayı hasar gören bölgeleri onarmayın ve kenarlarını kesmeyin • Medikal ürünü organik çözücülerden ve ağartıcı maddelerden uzak tutun

Kdy nepoužívat: Zdravotnický prostředek ihned přestaňte používat pokud: • se objeví známky mechanického poškození (kompresivní punčochový zdravotnický prostředek vyměňte za nový) • pozorujete zhoršení zdravotního stavu, které by mohlo mít souvislost s používáním kompresivního zdravotnického prostředku - v takovém případě se poraďte se svým ošetřujícím lékařem Kontraindikace: • akutní mokvající kožní projevy • akutní končetinová ischemie • kritická končetinová ischemie • dekompenzovaná kardiální insuficience • phlegmazia coerulea dolens, phlegmazia alba dolens • přecitlivělost na použité materiály • poruchy citlivosti končetin (např. periferní neuropatie při diabetes mellitus)

When not to use: Stop using the product immediately if any of the following conditions apply: • There are signs of mechanical damage – replace with new compression medical stockings • You notice a deterioration in your health that may be associated with the use of the compression medical device – consult your doctor in such case Contraindications: • Acute weeping skin manifestations • Acute limb ischaemia • Critical limb ischaemia • Decompensated cardiac insufficiency • Phlegmasia cerulea dolens, phlegmasia alba dolens • Hypersensitivity to materials used • Limb numbness disorders (e.g. peripheral neuropathy in diabetes mellitus)

Kiedy nie używać: Należy natychmiast zaprzestać użytkowania wyrobu medycznego gdy: • pojawią się oznaki mechanicznego uszkodzenia (kompresyjny medyczny wyrób pończoszniczy należy wymienić na nowy) • zauważysz niepokojącą zmianę stanu zdrowia, która może wynikać z używania kompresyjnego wyrobu medycznego – w takim wypadku skontaktuj się ze swoim lekarzem prowadzącym Przeciwwskazania: • uciążliwe sączące się uszkodzenia skóry • ostre niedokrwienie kończyn • krytyczne niedokrwienie kończyn • zdekompensowana niewydolność serca • phlegmazia coerulea dolens, phlegmazia alba dolens • nadwrażliwość na użyte materiały • zaburzenia tkliwości kończyn (np. neuropatia peryferyjna przy diabetes mellitus)

Kedy nepoužívať: Zdravotnícku pomôcku ihneď prestaňte používať, ak: • sa na nej objavia známky mechanického poškodenia (kompresívnu zdravotnícku pomôcku vymeňte za novú) • pozorujete zhoršenie zdravotného stavu, ktoré by mohlo mať súvislosť s používaním kompresívnej zdravotníckej pomôcky – v takom prípade sa poraďte so svojím ošetrujúcim lekárom Kontraindikácie: • akútne mokvajúce kožné prejavy • akútna končatinová ischémia • kritická končatinová ischémia • dekompenzovaná srdcová nedostatočnosť • phlegmazia coerulea dolens, phlegmazia albumu dolens • precitlivenosť na použité materiály • poruchy citlivosti končatín (napr. periférna neuropatia pri diabetes mellitus)

Quand ne pas l’utiliser : Cessez immédiatement d’utiliser le produit si l’une des conditions suivantes s’applique : • Il y a des signes de dommages mécaniques. Remplacez par des nouveaux bas de compression médicale • Vous constatez une détérioration de votre état de santé qui pourrait être associée à l’utilisation du dispositif médical - consultez votre médecin Contre-indications : • Manifestations cutanées aiguës et suintantes • Ischémie aiguë des membres • Ischémie critique des membres • Insuffisance cardiaque décompensée • Phlegmasia cerulea dolens, phlegmasia alba dolens • Hypersensibilité aux matériaux utilisés • Engourdissement des membres (par exemple, neuropathie périphérique en cas de diabète sucré)

Nicht verwenden: Brechen Sie die Anwendung des Medizinproduktes sofort ab, wenn: • Anzeichen einer mechanischen Beschädigung auftreten (ersetzen Sie den medizinischen Kompressionsstrumpf durch einen neuen) • Sie eine Verschlechterung Ihres Gesundheitszustands beobachten, die mit der Anwendung des medizinischen Kompressionsstrumpfs im Zusammenhang stehen könnte – beraten Sie sich in einem solchen Fall mit Ihrem behandelnden Arzt Kontraindikation: • akute nässende Hautausschläge • akute Ischämie der Gliedmaßen • kritische Ischämie der Gliedmaßen • dekompensierte kardiale Insuffizienz • Phlegmazia coerulea dolens, Phlegmazia alba dolens • Überempfindlichkeit gegenüber den verwendeten Materialien • Störungen der Empfindlichkeit der Gliedmaßen (z. B. periphere Neuropathie bei Diabetes mellitus)

Ne zaman kullanılmamalıdır: Aşağıdaki koşullardan herhangi biri geçerliyse ürünü kullanmayı derhal bırakın: • Mekanik hasar belirtileri varsa yeni kompresyon çorapları ile değiştirin • Sağlığınızda medikal kompresyon ürünü kullanımıyla ilişkili olabilecek bir bozulma fark ederseniz, böyle bir durumda doktorunuza danışın Kontrendikasyonlar: • Akut sızıntılı deri bulguları • Akut uzuv iskemisi • Kritik uzuv iskemisi • Dekompanse kalp yetmezliği • Phlegmasia cerulea dolens, phlegmasia alba dolens • Kullanılan materyallere karşı aşırı hassasiyet • Uzuv uyuşma bozuklukları (örn. diabetes mellitusta periferik nöropati)


Vaporizer

Serenity S Vaporizer PIRAMAL SEV Piramal-Fill FR, DE, NL, IT, EN CEE 7/7 Power Cord

Lead (Pb)

Boron Trioxide (B2O3)

ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES

57 to 106 kPa

-25ºC to +40ºC; Up to 95% RH, non-condensing / +40ºC to +50ºC; Up to 85% RH, non-condensing / +50ºC to +60ºC; Up to 55% RH, non-condensing

-25ºC to +60ºC (Protect the vaporizer packaging from condensation).


Vaporizer

Serenity S Vaporizer PIRAMAL SEV Piramal-Fill EN-UK BS1363A Power Cord

Lead (Pb)

Boron Trioxide (B2O3)

57 to 106 kPa


Uchwyt Kątowy Prawy 60x40 cm z maskownicami UKP-6/4 M fi 32

HANDLES


Uchwyt Kątowy Lewy 60x40 cm z maskownicami UKL-6/4 M fi 32

HANDLES


Vaporizer

Serenity S Vaporizer PIRAMAL SEV Piramal-Fill EN-UK CEE 7/7 Power Cord

Lead (Pb)

Boron Trioxide (B2O3)

57 to 106 kPa


Uchwyt umywalkowy prawy z maskownicami 60 cm UUP-6 M fi 32

HANDLES


Uchwyt Umywalkowy Lewy 60 cm z maskownicami UUL-6M fi 32

HANDLES


Uchwyt umywalkowy prawy 50 cm z maskownicami UUP-5 M fi 32

HANDLES


Vaporizer

Serenity S Vaporizer BAXTER SEV Safe-T-Seal DA

Lead (Pb)

Boron Trioxide (B2O3)

ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES

57 to 106 kPa

-25ºC to +40ºC; Up to 95% RH, non-condensing / +40ºC to +50ºC; Up to 85% RH, non-condensing / +50ºC to +60ºC; Up to 55% RH, non-condensing

-25ºC to +60ºC (Protect the vaporizer packaging from condensation).


ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER


Uchwyt Umywalkowy Lewy 50 cm z maskownicami UUL-5M fi 32

HANDLES


Uchwyt do WC Prawy 80x80 cm Ściana/Podłoga z maskownicami UWCP-8 M fi 32

HANDLES


Uchwyt do WC Prawy 80x80 cm Ściana/Podłoga UWCP-8 fi 32

HANDLES


Intended for use in lifting or transferring people with reduced mobility.

Winncare

PATIENT TRANSFER LIFTS - OTHER

78 cm x 100 cm


Vaporizer

Serenity S Vaporizer BAXTER SEV Safe-T-Seal DE, FR, IT, ES, EN CEI 23-50 Power Cord

Lead (Pb)

Boron Trioxide (B2O3)

57 to 106 kPa


Vaporizer

Serenity S Vaporizer BAXTER SEV Safe-T-Seal RO, ES, PT, EL, ET CEE 7/7 Power Cord

Lead (Pb)

Boron Trioxide (B2O3)

57 to 106 kPa


Winncare

PATIENT TRANSFER LIFTS - OTHER

68 cm x 100 cm


Das Medizinprodukt ist zur Kompressionstherapie von venösen Erkrankungen und Schwellungen der unteren Gliedmaßen unterschiedlichen Ursprungs bestimmt.

Wyrób medyczny jest przeznaczony do terapii kompresyjnej w leczeniu chorób żylnych i różnego pochodzenia obrzęków kończyn dolnych.

Zdravotnický prostředek určený ke kompresivní terapii žilních onemocnění a otoků různého původu dolních končetin.

Ce dispositif médical est destiné à la thérapie par compression des troubles circulatoires et des différents types d’oedèmes de la jambe.

Bu medikal ürün, dolaşım bozukluklarının ve bacaktaki çeşitli ödem türlerinin kompresyon yoluyla tedavi edilmesi amacıyla tasarlanmıştır.

The medical device intended for the compression therapy of venous conditions and swelling of the legs of various origin.

Zdravotnícka pomôcka určená na kompresívnu terapiu žilových ochorení a opuchov rôzneho pôvodu dolných končatín.

Avicenum PHLEBO 70 punčochové kalhoty

Avicenum PHLEBO 70 tights

Avicenum PHLEBO 70 rajstopy

Avicenum PHLEBO 70 pančuchové nohavice

Avicenum PHLEBO 70 collants

Avicenum PHLEBO 70 Strumpfhose

Avicenum PHLEBO 70 Külotlu çorap

COMPRESSION STOCKINGS

XL+

closed toe, large gusset

• zdravotní punčochy lze prát v pračce (maximální teplota praní 30°C, mírný postup), nejlépe v ochranném obalu (prací sáček) • nepoužívejte aviváž • sušte ve vodorovné poloze mimo přímý zdroj tepla (radiátor, slunce) • zdravotnické prostředky nežehlete • maximální možný počet pracích cyklů je 120 • skladujte v suchu a temnu, nejlépe v originálním obalu • do zdravotnických prostředků nijak mechanicky nezasahujte, neopravujte místa poškozená používáním, nenastřihávejte okraje • zdravotnické prostředky nesmí přijít do styku s organickými rozpouštědly, bělícími přípravky

• Medical socks can be washed in a washing machine (maximum wash temperature 30°C, gentle cycle), preferably in a protective cover (wash bag) • Do not use fabric softener • Lay flat to dry away from sources of direct heat (radiator, sunlight) • Do not iron medical devices • Maximum number of washing cycles is 120 • Store in a dark, dry place in the original packaging if possible • Do not make mechanical changes to the medical device, do not repair areas damaged by use, do not trim the edges • Keep the medical device away from organic solvents and bleaching agents

• wyroby medyczne można prać w pralce (maksymalna temperatura prania 30°C, program delikatny), najlepiej w opakowaniu ochronnym (worek do prania) • nie używać płynu do płukania tkanin • suszyć w pozycji poziomej nie wystawiając na bezpośrednie działanie źródła ciepła (grzejnik, słońce) • nie prasować wyrobów medycznych • maksymalna liczba cykli prania to 120 • przechowywać w suchym i ciemnym miejscu, najlepiej w oryginalnym opakowaniu • nie ingerować mechanicznie w wyroby medyczne, nie naprawiać miejsc uszkodzonych w wyniku użytkowania, nie przycinać krawędzi • wyroby medyczne nie mogą mieć kontaktu z rozpuszczalnikami organicznymi, środkami wybielającymi

• zdravotné pančuchy sa môžu prať v práčke (maximálna teplota prania 30 °C, šetrný cyklus), najlepšie v ochrannom obale (vrecko na pranie) • nepoužívajte aviváž • sušte vo vodorovnej polohe mimo priameho zdroja tepla (radiátor, slnko) • zdravotnícke pomôcky nežehlite • maximálny možný počet pracích cyklov je 120 • skladujte v suchu a v tme, najlepšie v originálnom obale • do zdravotníckych pomôcok nijako mechanicky nezasahujte, neopravujte miesta poškodené používaním, nenastrihávajte okraje • zdravotnícke pomôcky nesmú prísť do styku s organickými rozpúšťadlami, bieliacimi prípravkami

• Les chaussettes médicales peuvent être lavées en machine (température maximale de lavage 30°C, cycle délicat), de préférence dans une housse de protection (sac de lavage) • Ne pas utiliser d’assouplissants • Sécher à plat, à l’abri de toute source de chaleur directe (radiateur, soleil) • Ne pas repasser les dispositifs médicaux • Le nombre maximum de cycles de lavage est de 120 • Conservez le produit dans un endroit sombre et sec, si possible dans l’emballage d’origine • Ne pas apporter de modifications mécaniques au dispositif médical, ne pas réparer les zones endommagées par l’utilisation, ne pas découper les bords • Conservez le dispositif médical à l’écart des solvants organiques et des agents de blanchiment

• die medizinischen Socken können in der Waschmaschine gewaschen werden (maximale Waschtemperatur 30 °C, Schonwaschgang), vorzugsweise in einer Schutzhülle (Waschbeutel) • keinen Weichspüler verwenden • in waagerechter Lage ohne direkten Kontakt zu Wärmequellen (Heizkörper, Sonne) trocknen • Medizinprodukte nicht bügeln • maximal 120 Waschzyklen möglich • an einem trockenen und dunklen Ort lagern, vorzugsweise in der Originalverpackung • keine mechanischen Eingriffe an Medizinprodukten vornehmen, keine durch den Gebrauch beschädigten Stellen reparieren, Kanten nicht anschneiden • die Medizinprodukte dürfen nicht in Kontakt mit organischen Lösungsmitteln oder Bleichmitteln kommen

• Medikal çoraplar çamaşır makinesinde (maksimum yıkama sıcaklığı 30°C, hassas yıkama), koruyucu bir kılıf (yıkama torbası) kullanarak yıkanabilir • Yumuşatıcı kullanmayınız • Kuruması için doğrudan ısı kaynağından (radyatör, doğrudan güneş ışığı) uzakta düz bir zemine serin • Medikal ürünleri ütülemeyin • Maksimum 120 defa yıkanabilir • Mümkünse orijinal paketinde karanlık ve kuru bir yerde saklayınız • Medikal ürün üzerinde mekanik değişiklikler yapmayın, kullanımdan dolayı hasar gören bölgeleri onarmayın ve kenarlarını kesmeyin • Medikal ürünü organik çözücülerden ve ağartıcı maddelerden uzak tutun

Kdy nepoužívat: Zdravotnický prostředek ihned přestaňte používat pokud: • se objeví známky mechanického poškození (kompresivní punčochový zdravotnický prostředek vyměňte za nový) • pozorujete zhoršení zdravotního stavu, které by mohlo mít souvislost s používáním kompresivního zdravotnického prostředku - v takovém případě se poraďte se svým ošetřujícím lékařem Kontraindikace: • akutní mokvající kožní projevy • akutní končetinová ischemie • kritická končetinová ischemie • dekompenzovaná kardiální insuficience • phlegmazia coerulea dolens, phlegmazia alba dolens • přecitlivělost na použité materiály • poruchy citlivosti končetin (např. periferní neuropatie při diabetes mellitus)

When not to use: Stop using the product immediately if any of the following conditions apply: • There are signs of mechanical damage – replace with new compression medical stockings • You notice a deterioration in your health that may be associated with the use of the compression medical device – consult your doctor in such case Contraindications: • Acute weeping skin manifestations • Acute limb ischaemia • Critical limb ischaemia • Decompensated cardiac insufficiency • Phlegmasia cerulea dolens, phlegmasia alba dolens • Hypersensitivity to materials used • Limb numbness disorders (e.g. peripheral neuropathy in diabetes mellitus)

Kiedy nie używać: Należy natychmiast zaprzestać użytkowania wyrobu medycznego gdy: • pojawią się oznaki mechanicznego uszkodzenia (kompresyjny medyczny wyrób pończoszniczy należy wymienić na nowy) • zauważysz niepokojącą zmianę stanu zdrowia, która może wynikać z używania kompresyjnego wyrobu medycznego – w takim wypadku skontaktuj się ze swoim lekarzem prowadzącym Przeciwwskazania: • uciążliwe sączące się uszkodzenia skóry • ostre niedokrwienie kończyn • krytyczne niedokrwienie kończyn • zdekompensowana niewydolność serca • phlegmazia coerulea dolens, phlegmazia alba dolens • nadwrażliwość na użyte materiały • zaburzenia tkliwości kończyn (np. neuropatia peryferyjna przy diabetes mellitus)

Kedy nepoužívať: Zdravotnícku pomôcku ihneď prestaňte používať, ak: • sa na nej objavia známky mechanického poškodenia (kompresívnu zdravotnícku pomôcku vymeňte za novú) • pozorujete zhoršenie zdravotného stavu, ktoré by mohlo mať súvislosť s používaním kompresívnej zdravotníckej pomôcky – v takom prípade sa poraďte so svojím ošetrujúcim lekárom Kontraindikácie: • akútne mokvajúce kožné prejavy • akútna končatinová ischémia • kritická končatinová ischémia • dekompenzovaná srdcová nedostatočnosť • phlegmazia coerulea dolens, phlegmazia albumu dolens • precitlivenosť na použité materiály • poruchy citlivosti končatín (napr. periférna neuropatia pri diabetes mellitus)

Quand ne pas l’utiliser : Cessez immédiatement d’utiliser le produit si l’une des conditions suivantes s’applique : • Il y a des signes de dommages mécaniques. Remplacez par des nouveaux bas de compression médicale • Vous constatez une détérioration de votre état de santé qui pourrait être associée à l’utilisation du dispositif médical - consultez votre médecin Contre-indications : • Manifestations cutanées aiguës et suintantes • Ischémie aiguë des membres • Ischémie critique des membres • Insuffisance cardiaque décompensée • Phlegmasia cerulea dolens, phlegmasia alba dolens • Hypersensibilité aux matériaux utilisés • Engourdissement des membres (par exemple, neuropathie périphérique en cas de diabète sucré)

Nicht verwenden: Brechen Sie die Anwendung des Medizinproduktes sofort ab, wenn: • Anzeichen einer mechanischen Beschädigung auftreten (ersetzen Sie den medizinischen Kompressionsstrumpf durch einen neuen) • Sie eine Verschlechterung Ihres Gesundheitszustands beobachten, die mit der Anwendung des medizinischen Kompressionsstrumpfs im Zusammenhang stehen könnte – beraten Sie sich in einem solchen Fall mit Ihrem behandelnden Arzt Kontraindikation: • akute nässende Hautausschläge • akute Ischämie der Gliedmaßen • kritische Ischämie der Gliedmaßen • dekompensierte kardiale Insuffizienz • Phlegmazia coerulea dolens, Phlegmazia alba dolens • Überempfindlichkeit gegenüber den verwendeten Materialien • Störungen der Empfindlichkeit der Gliedmaßen (z. B. periphere Neuropathie bei Diabetes mellitus)

Ne zaman kullanılmamalıdır: Aşağıdaki koşullardan herhangi biri geçerliyse ürünü kullanmayı derhal bırakın: • Mekanik hasar belirtileri varsa yeni kompresyon çorapları ile değiştirin • Sağlığınızda medikal kompresyon ürünü kullanımıyla ilişkili olabilecek bir bozulma fark ederseniz, böyle bir durumda doktorunuza danışın Kontrendikasyonlar: • Akut sızıntılı deri bulguları • Akut uzuv iskemisi • Kritik uzuv iskemisi • Dekompanse kalp yetmezliği • Phlegmasia cerulea dolens, phlegmasia alba dolens • Kullanılan materyallere karşı aşırı hassasiyet • Uzuv uyuşma bozuklukları (örn. diabetes mellitusta periferik nöropati)


Intended for use in lifting or transferring people with reduced mobility.

Winncare

PATIENT TRANSFER LIFTS - OTHER

52 cm x 100 cm


Vaporizer

Serenity S Vaporizer BAXTER SEV Safe-T-Seal KK, LV, LT, RU, UK CEE 7/7 Power Cord

Lead (Pb)

Boron Trioxide (B2O3)

ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES

57 to 106 kPa

-25ºC to +40ºC; Up to 95% RH, non-condensing / +40ºC to +50ºC; Up to 85% RH, non-condensing / +50ºC to +60ºC; Up to 55% RH, non-condensing

-25ºC to +60ºC (Protect the vaporizer packaging from condensation).


Winncare

PATIENT TRANSFER LIFTS - OTHER

48 cm x 91 cm


Winncare

PATIENT TRANSFER LIFTS - OTHER

42 cm x 80 cm


Winncare

PATIENT TRANSFER LIFTS - OTHER

78 cm x 75 cm


Winncare

PATIENT TRANSFER LIFTS - OTHER

68 cm x 75 cm


Malecot Drainage Catheter Exchange Set

NEPHROSTOMY CATHETERS


Bioceramic reparative material ready to use.

EdgeUtopia RRM 1.5 g

ROOT CANAL FILLING DENTAL CEMENTS

Keep the product between 15°C and

Keep the product with relative humidity below 60%.

Do not store the product near ammonia, ammonium nitrate and products containing chlorine. Avoid the use of disinfecting solutions containing any of these ingredients.


Bioceramic root canal sealer ready to use.

EdgeUtopia BioCeramic Sealer 2 g

ROOT CANAL FILLING DENTAL CEMENTS

Keep the product between 15°C and 30°C.


Malecot Drainage Catheter Suprapubic Set

DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER


Opal model 1098 is intended to measure and analyze daily radiation output and positioning characteristics of a Cobalt 60 or LINAC Treatment Delivery Device before the start of daily treatment in a radiation oncology center and not for calibration of said machines.

Daily QA 4 Pro

LINEAR ACCELERATORS - HARDWARE ACCESSORIES

5 °C

50 °C

10 - 90%


The Low-Profile Gastrostomy Replacement Tube (G. Button) Kit with the main component being the G. Button. The G. Button is a silicone feeding device comprised of a body,
two‑lumen shafts, and a retaining balloon. The G. Button body has two ports and a strap with a cap. The first port with a feeding ring and duckbill valve connected to the lumen
for feeding and or medication. The second port with an inflation valve is connected to the lumen for balloon inflation. The device is translucent with an X-Ray line (silicone base
with BaSO4 - Barium sulphate) for X-ray determination of the tube position in the patient body.
The device is packed with accessories into a kit

GASTROSTOMY, TUBES AND SETS

For Enteral Feeding only. For use with Extension Feeding Set with ENFit connectors.
It is highly recommended to consult the instructions before use


CERTUS OVERFLATEDESINFEKSJON 85%, 4L

ETHANOL FOR THE DISINFECTION OF MEDICAL DEVICES

-18 to 30 Celsius


The Low-Profile Gastrostomy Replacement Tube (G. Button) Kit with the main component being the G. Button. The G. Button is a silicone feeding device comprised of a body,
two‑lumen shafts, and a retaining balloon. The G. Button body has two ports and a strap with a cap. The first port with a feeding ring and duckbill valve connected to the lumen
for feeding and or medication. The second port with an inflation valve is connected to the lumen for balloon inflation. The device is translucent with an X-Ray line (silicone base
with BaSO4 - Barium sulphate) for X-ray determination of the tube position in the patient body.
The device is packed with accessories into a kit

GASTROSTOMY, TUBES AND SETS

For Enteral Feeding only. For use with Extension Feeding Set with ENFit connectors.
It is highly recommended to consult the instructions before use.


GASTROSTOMY, TUBES AND SETS

For Enteral Feeding only. For use with Extension Feeding Set with ENFit connectors.
It is highly recommended to consult the instructions before use


GASTROSTOMY, TUBES AND SETS


Adhesive Drape

SURGICAL DRAPES - OTHER

Do not re-use

Do not resterilize

Do not use if package is damaged