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The Medical Treatment Chair, T688 Series is intended for use in medical procedures such The Medical Preatinent Chalysis to, and collecting blood from, patients in hospital departments or home use, under the supervision of trained medical staff. The Medical Treatment Chair is also intended for use in day surgery and nursing homes. T688 chair is I readined so that the occupant is accommodated in a seated position with the hips moved designed so that the occupant is against the back rest and the legs outstretched and supported by the seat and leg rests.

T688 chair is also used to position patients for easy access by healthcare professionals. The I voo enair is designed so that the occupant is accommodated in a seated position with the hips enair is decired or that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests.

This chair is intended to be used by patients with a weight not exceeding:

• 200kg (T688 series) .

T688 series chair is used to aid medical procedures such as renal dialysis, blood collection and chemotherapy and is called as Medical Treatment Chair.

T688 series is electric-powered treatment chair with the following features:

• Power-operated seat and leg rest and back rest reclines, with options offering one-. touch memorized positions
• Swing Out Side/Arms .
• Adjustable head/neck rest .
• Adjustable height .
• CPR support posts, gas spring assisted back rest and accessories. .
• . Fold-down trays
• Four individually locking castors .
• Heavy duty washable vinyl .
• Removable upholstery .
• The chair will recline to Trendelenburg position .
• Suitable for side transfer of patients .
• No timber included in the frame .
• Battery back-up-24V rechargeable .
• 2 Actuators & 1 Column .
• Compact Design .
• Lighter weight .
• Reduced components ●

The device is classified as:

• Class II (FKS, INO) electric-powered version. .
  Specific ancillary devices and accessories are not listed here due to the wide variety of procedures in which the chair is used.

The Fresenius Medical Treatment Chair T688 Series is a medical treatment chair designed for use in medical procedures such as renal dialysis, blood collection, and chemotherapy, under the supervision of trained medical staff. It is also intended for use in day surgery and nursing homes.

Here's an analysis of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

• Length Tren/CPR: 1800 mm
• Overall Width: 730 mm
• Seat Width: 510 mm
• Seat Height to Floor: 590 mm
• Backrest Length: 800 mm |

2. Sample Size Used for the Test Set and the Data Provenance

The document states that "Representative samples for the device underwent load and repeatability testing to verify functional and performance characteristics." It does not specify the exact sample size for these tests. There is no information provided regarding data provenance (e.g., country of origin of the data, retrospective or prospective) for any of the testing mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This device is a medical treatment chair, and its performance is evaluated against engineering standards and functional requirements, not against ground truth established by experts in a diagnostic context.

4. Adjudication Method for the Test Set

Not applicable, as the testing involves engineering and performance standards rather than subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, which is not the case for a medical treatment chair.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The device is a physical medical chair and does not involve an algorithm for standalone performance. Its performance is assessed through physical and electrical testing against established standards.

7. The Type of Ground Truth Used

The ground truth for this device is based on engineering standards, functional specifications, and safety requirements. This includes:

• Specified weight capacity (200 kg).
• Compliance with various ISO, IEC, AS/NZS, BS EN standards for biocompatibility, electrical safety, EMC, flame retardancy, quality management, risk analysis, and component specifications (e.g., castors).
• Internal "self-imposed load and repeatability test requirements" to verify functional and performance characteristics.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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