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SAFE Med Leg and Arm support for the operating room, pressure relief

SAFE Med Leg and Arm support for the operating room, pressure relief
SAFE Med Leg support and Armsupport in pressure relieving SAFE ViscoPore foam with black COMFOR OP-cover with glued seams. Foam core and cover can be machine washed at 95C and autoclaved at 134C-to tumble dry. Daily cleaning of cover with soapy water, alcohol solution or Wet Wipe Chlorine Disinfection or similar with active chlorine 1000-1200 ppm.

Classification
09 07 06 06 - Leg positioners and arm positioners

Documents


The product series contains 6 products.

Product 1 of 6
Arm support for arm table for surgical patients, 62x17,5x2,5 cm


HMI-no.
139553
Article-no.
129ICOP.62/17,5

Registration date
10-01-2024
Last updated
15-01-2024

Properties
Shape
Rektangulær

Properties
Filling
Skum
Intended for children
No
info
Products for children must comply with the specific demands for safety as stated in certain standards. The supplier of the product has stated that the product is intended for children. The Danish Authority of Social Services and Housing holds no responsibility in relation to this assessment.
(Optional) machine washable cover
Yes
(Optional) cover which can be autoclaved
Yes
(Optional) cover which can be disinfected
Yes
Machine washable cushion
Yes
Cushion can be autoclaved
Yes
Cushion can be tumble dried
Yes
Flame resistant
Yes
Hypoallergenic
Yes
For arm or hand
Yes
For leg or foot
No

Measures
Length
62
cm
Width
17.5
cm
Height
2.5
cm

Test information info
Though the product is testet, it might not have passed all requirements in the standard. Besides, some products are only tested according to parts of the standard. Read the test report for detailed information. See also other standards that could be relevant for this product type.
: Tested according to other national or international standard.
Test lab: Swerea IVF AB. Test date: 07-11-2018 Test report for HMI-no. 139553

EU product safety regulation info
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 2 of 6
Arm support for arm table for surgical patients, 62x20x2,5 cm


HMI-no.
139564
Article-no.
129ICOP.6220

Registration date
10-01-2024
Last updated
15-01-2024

Properties
Shape
Rektangulær

Properties
Filling
Skum
Intended for children
No
info
Products for children must comply with the specific demands for safety as stated in certain standards. The supplier of the product has stated that the product is intended for children. The Danish Authority of Social Services and Housing holds no responsibility in relation to this assessment.
(Optional) machine washable cover
Yes
(Optional) cover which can be autoclaved
Yes
(Optional) cover which can be disinfected
Yes
Machine washable cushion
Yes
Cushion can be autoclaved
Yes
Cushion can be tumble dried
Yes
Flame resistant
Yes
Hypoallergenic
Yes
For arm or hand
Yes
For leg or foot
No

Measures
Length
62
cm
Width
20
cm
Height
2.5
cm

Test information info
Though the product is testet, it might not have passed all requirements in the standard. Besides, some products are only tested according to parts of the standard. Read the test report for detailed information. See also other standards that could be relevant for this product type.
: Tested according to other national or international standard.
Test lab: Swerea IVF AB. Test date: 07-11-2018 Test report for HMI-no. 139564

EU product safety regulation info
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 3 of 6
Arm support for arm table for surgical patients, 62x25x2,5 cm


HMI-no.
139568
Article-no.
129ICOP.6225

Registration date
10-01-2024
Last updated
15-01-2024

Properties
Shape
Rektangulær

Properties
Filling
Skum
Intended for children
No
info
Products for children must comply with the specific demands for safety as stated in certain standards. The supplier of the product has stated that the product is intended for children. The Danish Authority of Social Services and Housing holds no responsibility in relation to this assessment.
(Optional) machine washable cover
Yes
(Optional) cover which can be autoclaved
Yes
(Optional) cover which can be disinfected
Yes
Machine washable cushion
Yes
Cushion can be autoclaved
Yes
Cushion can be tumble dried
Yes
Flame resistant
Yes
Hypoallergenic
Yes
For arm or hand
Yes
For leg or foot
Yes

Measures
Length
62
cm
Width
25
cm
Height
2.5
cm

Test information info
Though the product is testet, it might not have passed all requirements in the standard. Besides, some products are only tested according to parts of the standard. Read the test report for detailed information. See also other standards that could be relevant for this product type.
: Tested according to other national or international standard.
Test lab: Swerea IVF AB. Test date: 07-11-2018 Test report for HMI-no. 139568

EU product safety regulation info
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 4 of 6
Arm support for arm table to surgical patients, pressure relief


HMI-no.
130154
Article-no.
129ICOP.5030

Registration date
12-08-2021
Last updated
10-01-2024

Properties
Shape
Rektangulær

Properties
Filling
Skum
Intended for children
No
info
Products for children must comply with the specific demands for safety as stated in certain standards. The supplier of the product has stated that the product is intended for children. The Danish Authority of Social Services and Housing holds no responsibility in relation to this assessment.
(Optional) machine washable cover
Yes
(Optional) cover which can be autoclaved
Yes
(Optional) cover which can be disinfected
Yes
Machine washable cushion
Yes
Cushion can be autoclaved
Yes
Cushion can be tumble dried
Yes
Flame resistant
Yes
Hypoallergenic
Yes
For arm or hand
Yes
For leg or foot
Yes

Measures
Length
50
cm
Width
30
cm
Height
2.5
cm

Test information info
Though the product is testet, it might not have passed all requirements in the standard. Besides, some products are only tested according to parts of the standard. Read the test report for detailed information. See also other standards that could be relevant for this product type.
: Tested according to other national or international standard.
Test lab: Swerea IVF AB. Test date: 07-11-2018 Test report for HMI-no. 130154

EU product safety regulation info
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 5 of 6
Leg and Arm support for surgical patients, 90x25x6 cm


HMI-no.
89425
Article-no.
128OP

Registration date
12-11-2015
Last updated
10-01-2024

Properties
Shape
Rektangulær

Properties
Filling
Skum
Intended for children
No
info
Products for children must comply with the specific demands for safety as stated in certain standards. The supplier of the product has stated that the product is intended for children. The Danish Authority of Social Services and Housing holds no responsibility in relation to this assessment.
(Optional) machine washable cover
Yes
(Optional) cover which can be autoclaved
Yes
(Optional) cover which can be disinfected
Yes
Machine washable cushion
Yes
Cushion can be autoclaved
Yes
Cushion can be tumble dried
Yes
Flame resistant
Yes
Hypoallergenic
Yes
For arm or hand
Yes
For leg or foot
Yes

Measures
Length
90
cm
Width
25
cm
Height
6
cm

Test information info
Though the product is testet, it might not have passed all requirements in the standard. Besides, some products are only tested according to parts of the standard. Read the test report for detailed information. See also other standards that could be relevant for this product type.
: Tested according to other national or international standard.
Test lab: Swerea IVF AB. Test date: 07-11-2018 Test report for HMI-no. 89425

EU product safety regulation info
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Other specifications
Leg support and Arm support is used for positioning of patients during surgery in the operating room


Product 6 of 6
Leg and Arm support for surgical patients, pressure relief


HMI-no.
89426
Article-no.
129OP

Registration date
12-11-2015
Last updated
10-01-2024

Properties
Shape
Rektangulær

Properties
Filling
Skum
Intended for children
No
info
Products for children must comply with the specific demands for safety as stated in certain standards. The supplier of the product has stated that the product is intended for children. The Danish Authority of Social Services and Housing holds no responsibility in relation to this assessment.
(Optional) machine washable cover
Yes
(Optional) cover which can be autoclaved
Yes
(Optional) cover which can be disinfected
Yes
Machine washable cushion
Yes
Cushion can be autoclaved
Yes
Cushion can be tumble dried
Yes
Flame resistant
Yes
Hypoallergenic
Yes
For arm or hand
Yes
For leg or foot
Yes

Measures
Length
60
cm
Width
20
cm
Height
6
cm

Test information info
Though the product is testet, it might not have passed all requirements in the standard. Besides, some products are only tested according to parts of the standard. Read the test report for detailed information. See also other standards that could be relevant for this product type.
: Tested according to other national or international standard.
Test lab: Swerea IVF AB. Test date: 07-11-2018 Test report for HMI-no. 89426

EU product safety regulation info
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device