YY 0900-2013Walk training platform with suspension (English PDF)

3.1 Walk Training Platform with Suspension

Walk training platform with suspension refers to medical electric-driven rehabilitation equipment, which is constituted of frame for suspension and walk training platform.

3.3 Walk Training Platform

Walk training platform is an auxiliary device for patients' walk training; it is generally electric-driven.

5.1 Frame for Suspension

5.1.1 Lifting stroke

Frame for suspension's lifting stroke shall satisfy the requirements stipulated by the manufacturer; the deviation shall not be more than ± 5%.

5.1.5 Suspension belt

5.1.5.1 Adjustment and locking

The suspension belt shall be equipped with adjustment and locking device, and easily operable. Locking shall be safe and reliable; easily recognizable and safely operated.

It shall be manually operated without the help of any instruments.

5.2 Walk Training Platform

5.2.1 Timing setting

The walk training platform shall have timing function; the timing error shall not be more than ± 1% of the set value, and not more than ± 1 min at the maximum.

5.2.3 Gradient setting

In terms of walk training platform which has the function of gradient adjustment, gradient shall be continuously adjustable. It shall also have the function of adjustment indication; the deviation of gradient indication shall not exceed ± 10%.

5.2.4 Static load

The walk training platform shall be able to maintain intact after supporting 6 times of the normal load stipulated by the manufacturer.

5.2.5 Safety of unexpected power outage

As power supply recovers after unexpected power outage, the walk training platform would not automatically operate.

5.2.6 Emergency stop device

Except from the power switch, the equipment shall also provide an emergency stop button, which can stop the training program at any time. This button shall take effect with just one action. This emergency stop button shall also be set up in a position accessible to patients during their training.

5.3 Overall Requirements of Equipment

5.3.1 Stability

The whole equipment shall have smooth landing; the difference between the footing and the horizontal plane shall not be more than 2 mm. In addition, during usage, the equipment shall not waggle or generate any displacement; the angle of overturn shall not be less than 10°. After reliably positioning it, there shall be no displacement.

5.3.2 Operating noise

During normal operation, the noise of the equipment shall not be more than 60 dB (A- weighted).

5.4 Operation Instruction

The operation instruction shall satisfy the requirement in 6.8.2 in GB 9706.1-2007. Meanwhile, it shall also include the following content.

5.5 Safety Requirements

The equipment shall satisfy the requirement in GB 9706.1-2007.

If it is operated under medical electrical system, the equipment shall satisfy the requirement in GB 9706.15.

5.6 Environmental Test Requirements

The equipment's environmental test shall be conducted in accordance with the stipulation in GB/T 14710.

6.1 Frame for Suspension

6.1.1 Lifting stroke

Respectively adjust the lifting stroke to the lowest end and the highest end. Measure its height; it shall comply with the requirement in 5.1.1.

6.1.5 Suspension belt

6.1.5.1 Adjustment and locking device

Conduct the test in practical operation; it shall comply with the requirement in 5.1.5.1.

6.1.5.2 Width

Conduct the test in practical measurement; it shall comply with the requirement in 5.1.5.2.

6.2 Walk Training Platform

6.2.1 Timing setting

Select an appropriate timing, which shall not be less than 30 min; if the maximum set timing is less than 30 min, select the maximum set timing. Conduct the test in practical measurement; it shall comply with the requirement in 5.2.1.

6.2.3 Gradient setting

Conduct the test in practical operation and measurement; it shall comply with the requirement in 5.2.3.

6.2.4 Static load

Conduct the test in accordance with the requirement in 6.6 in GB 17498.6-2008; it shall comply with the requirement in 5.2.4.

6.2.5 Safety of unexpected power outage

Conduct the test in practical operation; it shall comply with the requirement in 5.2.5.

6.2.6 Emergency stop device

Conduct the test in visual inspection and practical operation; it shall comply with the requirement in 5.2.6.

6.2.7 Fatigue test

In the test, simulate the equipment's moving components in 100,000 times of no-load operation. After that, the equipment's function shall still satisfy the requirement in 5.2.7.

6.3 Overall Requirements of Equipment

6.3.1 Stability

Place the overall equipment on a flat surface; use a feeler gauge to measure the distance between the footing and the flat surface.

6.3.2 Operating noise

Place the equipment on a hard table and at a distance of at least 3 m from the walls or other reflectors. Under the environment where background noise is 10 dB lower than the measuring point in the sound pressure level, operate the equipment under normal working state where the maximum noise might be generated; measure A-weighted sound level in the front, the back, the left, the right and the top of the host device of the equipment; they shall all satisfy the requirement in 5.3.2. If the manufacturer stipulates equipment's special installation or arrangement conditions in the attached documents, the equipment can be arranged merely in accordance with the method stipulated by the manufacturer.

6.5 Safety Requirements

Conduct the test through visual inspection and practical operation; it shall comply with the requirement in 5.5.

6.6 Environmental Test Requirements

Conduct the test through visual inspection and practical operation; it shall comply with the requirement in 5.6.

6.7 Biocompatibility

Consult relevant documents; it shall comply with the requirement in 5.7.

7.1 Inspection Classification

Equipment's quality inspection shall be classified into exit-factory inspection and type inspection.

7.3 Type Inspection

7.3.1 Type inspection shall be conducted under one of the following circumstances.

7.3.2 Determination of type inspection. if products are qualified in all the inspection items, then, they shall be determined as qualified in type inspection. Otherwise, they shall be determined as unqualified in type inspection.

8.1 Marking

8.1.1 Nameplate marking

Nameplate shall be set up in an appropriate location on the equipment. Nameplate marking shall at least include the following content.

8.1.2 Marking on external packaging

When equipment has external packaging, it shall at least include the following markings.

8.1.3 Marking on product inspection conformity certificate

The marking on product inspection conformity certificate shall at least include the following content.

8.2 Operation Instruction

Operation instruction shall at least include the following content.

9.1 Packaging

9.1.1 Equipment shall be individually packed. The external packaging shall be able to prevent product from natural damage; packaging materials shall comply with the stipulation in the ordering contract.

9.1.5 Equipment shall have the following attached documents.

9.2 Transportation

Transportation requirements shall comply with the stipulation in the ordering contract.

9.3 Storage

Equipment shall be stored at the temperature of -40 °C ~ 55 °C; relative humidity shall not exceed 90%. Equipment shall be stored in well-ventilated interior, where there is no corrosive gas. […]