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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



The product series contains 3 products.

Product 1 of 3
Arm support for arm table to surgical patients, pressure relief


HMI-no.
130154
Article-no.
129OP.5030IC

Registration date
12-08-2021
Last updated
15-05-2023

Properties
Shape
Rektangulær

Properties
Filling
Skum
Intended for children
No
(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

CE-marking info
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
Medical Device Regulation (MDR) - 2017/745/EU


Product 2 of 3
Leg and Arm support for surgical patients, 90x25x6 cm

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

HMI-no.
89425
Article-no.
128OP

Registration date
12-11-2015
Last updated
15-05-2023

Properties
Shape
Rektangulær

Properties
Filling
Skum
Intended for children
No
(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

CE-marking info
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
Medical Device Regulation (MDR) - 2017/745/EU


Product 3 of 3
Leg and Arm support for surgical patients, pressure relief


HMI-no.
89426
Article-no.
129OP

Registration date
12-11-2015
Last updated
15-05-2023

Properties
Shape
Rektangulær

Properties
Filling
Skum
Intended for children
No
(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

CE-marking info
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
Medical Device Regulation (MDR) - 2017/745/EU