Winncare Axtair Pressure Area Management Systems

Technical Manual

Models Covered: Axtair One® Plus, Axtair Automorpho® Plus, Axtair Axensor® AT12/AT15/AT20, Axtair XXL®, Axtair APC

UDI: 366489700083H9

Manufacturer: WINNCARE France

Address: 200 Rue Charles Tellier, Actiparc de Grézan, 30000 Nîmes - France

Contact: Tél.: +33 (0)4 66 02 15 15, Fax.: +33 (0)4 66 02 15 00, Email: contact@winncare.fr, Website: www.winncare.com

Document Reference: PA0010177

Version: 8

Date: 26/02/2025

Product Specifications

Axtair One® Plus

Model Codes: VAXT2/ONE-P, VAXT2/ONE/CIC-P, VAXT/PONEP, VAXT/MONEP90/PUL, VAXT/MONEP90/CIC.

Specifications: Patient weight: 30-165 kg (67-364 lb); Max patient weight: 210 kg (463 lb); Noise level: <35 dBA; Mattress thickness: 12 cm; IP Rating: IP42; Mattress weight: 12.7 kg (28 lb); Cycle time: 9-14 min. Features CPR function. Alternating cycle frequency: 1 cell out of 2.

Axtair Automorpho® Plus

Model Codes: VAXT4/AUTO-P, VAXT4/CIC-P, VAXT4/AUTO100-P, VAXT4/CIC100-P, VAXT4/AUTO120-P, VAXT4/CIC120-P, VAXT/PAUTOP, VAXT/MAUTOP90/PUH, VAXT/MAUTOP90/CIC, VAXT/MAUTOP100/PUH, VAXT/MAUTOP100/CIC, VAXT/MAUTOP120/PUH, VAXT/MAUTOP120/CIC.

Specifications: Patient weight: 30-180 kg (67-397 lb); Max patient weight: 225 kg (496 lb); Noise level: <35 dBA; Mattress thickness: 12 cm; IP Rating: IP42; Mattress weight: 12.7-16 kg (28-35.3 lb); Cycle time: 9-15 min. Features CPR function and Care mode. Alternating cycle frequency: 1 cell out of 2.

Axtair Axensor® AT12

Model Codes: VAXT6/AUTO-S, VAXT6/AUTO-80-S, VAXT6/POMPE/AUTO-S, VAXT6/MA/AUTO, VAXT6/MA/AUTO-80.

Specifications: Patient weight: 30-165 kg (67-364 lb); Max patient weight: 210 kg (463 lb); Noise level: <35 dBA; Mattress thickness: 12 cm; IP Rating: IP42; Mattress weight: 12.6 kg (27.8 lb); Cycle time: 17-20 min. Features Care mode. Alternating cycle frequency: 1 cell out of 2.

Axtair Axensor® AT15

Model Codes: VAXT6/MAX-S, VAXT6/MAX-DV-S, XT6/POMPE/AUTO-S, VAXT6/MA/MAX, VAXT6/MA/MAX-DV.

Specifications: Patient weight: 30-180 kg (67-397 lb); Max patient weight: 225 kg (496 lb); Noise level: <35 dBA; Mattress thickness: 15.5 cm; IP Rating: IP42; Mattress weight: 14 kg (31 lb); Cycle time: 17-20 min. Features Care mode. Alternating cycle frequency: 1 cell out of 2.

Axtair Axensor® AT20

Model Codes: VAXT6/AT20-80-S, VAXT6/AT20-90-S, VAXT6/POMPE/AUTO-S, VAXT6/MA/AT20-80, VAXT6/MA/AT20-90.

Specifications: Patient weight: 30-200 kg (67-441 lb); Max patient weight: 245 kg (540 lb); Noise level: <35 dBA; Mattress thickness: 20 cm; IP Rating: IP42; Mattress weight: 14.2 kg (31.3 lb); Cycle time: 17-20 min. Features Care mode. Alternating cycle frequency: 1 cell out of 2.

Axtair XXL®

Model Codes: VAXT/XXL-120, VAXT/XXL-140, VAXT/POMPE/XXL, VAXT/MA/120XXL, VAXT/MA/140XXL.

Specifications: Patient weight: 100-270 kg (220-595 lb); Max patient weight: 315 kg (695 lb); Noise level: <35 dBA; Mattress thickness: 20 cm; IP Rating: IP42; Mattress weight: 23.5-25.5 kg (51.8-56.2 lb); Cycle time: 9-15 min. Features Care mode. Alternating cycle frequency: 1 cell out of 2.

1. Indications

Device Intended Use

Pressure area management systems and associated pumps are intended for medical use in the treatment and prevention of pressure ulcers/injuries.

Indications

Prevention and support for the treatment of stage 1 to 4 pressure ulcers/injuries (according to medical opinion) for patients who may or may not be up during the day, and/or have a "moderate to very high" risk of developing a pressure ulcer/injury, assessed according to a proven scale and based on clinical judgement.

Contraindications

Patients with a minimum or maximum weight outside the tolerated range for the mattress/cushion. Non-stabilized post-traumatic fractures (when using dynamic mode). Use in hyperbaric chambers and on stretchers.

Intended Target Patient Population

Hospitalized, institutionalized, or home-based adults over 146 cm in height, with one or more pressure ulcers/injuries, or at risk of developing pressure ulcers/injuries due to temporary or definitive alteration of their condition.

Intended Target Group of Users

Healthcare professionals, assisted by carers where necessary.

Undesirable Effects

Inform the competent authority if the device presents a serious risk or has been tampered with. All serious incidents related to the device must be notified to the manufacturer and the competent authority of the member state where the user and/or patient resides.

2. Medical Device Composition

More detailed information on the APC cushion is provided on the last page.

Components:

Compressor Axensor.
Hooks system for hanging up to the medical bed.
Power supply cable.
Alternating-cell mattresses, with two static head cells (except on One Plus).
Heel discharge cells with individual deflation valves (specific counts vary by model).
Polyurethane foam base (except for Axensor AT20 and XXL mattresses).
Pneumatic connector with a plug for rebalancing support pressure when disconnected from the compressor.
CPR function (available on One Plus and Automorpho Plus).
Regulatory identification labels.
Instruction for Use (IFU).
Simplified instructions attached to the compressor.

Diagram Description: Illustration showing the components of the medical device, including a compressor unit, mattress, tubing, and power cable, with numbered callouts identifying specific parts.

3. Clinical Benefit, Performance, Mechanism of Action

Device Performance Characteristics

Operating Principle: Alternating pressure systems that alternately inflate and deflate cells.
Automatic Inflation Pressure Adjustment: System controls air supply and pressure, adapting to patient morphotype at start-up without external intervention.
"Dynamic" Mode: Alternating pressure prevents prolonged vascular compression, reducing tissue hypoxia.
Low Pressure "Static" Mode: Used for immobilization (orthopaedic, neurological trauma), local pain management, or withdrawal phases.
"Care" Mode: For patient handling, medical procedures, and transfers.

Expected Clinical Benefits

Maintains tissue oxygenation in anatomical areas in contact with the support surface by reducing pressure on the skin and subcutaneous tissue.

4. Instructions for Use

User Training and Qualification

All users (health professionals or not) must be trained by individuals approved by the economic operators regarding the functions they access, including safety and non-compliance reporting.

Device Installation

Steps:

Check compressor and mattress compatibility.
Mattress pre-inflation using quick inflation pumps.
Compressor inflation: Self-inflation can take 20 minutes (90 cm mattress) or 30 minutes (120 cm mattress). Wait before patient placement.
Patient placement: Can occur after quick inflation pump pre-inflation.

Diagram Description: Illustrations depicting installation steps: 1. Checking compressor and mattress. 2. Mattress with quick inflation pump. 3. Compressor unit. 4. Mattress connected to compressor.

Cleaning and Disinfection

Perform before first use and between each patient. Refer to WINNCARE Services sheets Cleaning Disinfection Air Mattresses n° 060 (protective cover n° 063) and consult the Technical Manual.

Preventive Maintenance

Check device every 2 years or after 17500 hours of operation (indicated by maintenance key LED).
Contact manufacturer/distributor for AIRCARE maintenance solutions (training, software, connection kit, revision kit).
Lifetime: 6 years (mattress and compressors).
Refer to the Technical Manual (downloadable from www.winncare.com).

5. Warnings, Precautions for Use

Precautions for Use

Use static low-pressure mode for non-stabilized bone/muscle injuries or in initial days post-surgery for pressure ulcers/injuries (skin graft/flap).
Identify a caregiver for technical or medical issues at home.
For patients > 135 kg, check for contact between gluteal region/bed base in semi-seated position (>45°) using a palm-up hand test.
Place a sheet between the mattress/cushion protection cover and the patient.
Ensure cushion dimensions are compatible with wheelchair seats.

Warnings

If the device alarm LED flashes or is on permanently, contact maintenance for troubleshooting.
Installation and commissioning must follow EMC information provided by WINNCARE France.
Observe specified storage and operating conditions.
Use only WINNCARE-specified accessories, cables, and covers.
Match compressor reference with its support.
Re-assess patient entrapment risk with bedrails and mattresses (EN 60601-2-52).
Do not use high-pressure jets for cleaning/disinfection.
Only one individual deflation valve should be open at a time.

Action Required (Pressure Ulcer/Injury Prevention)

Observe skin condition several times daily.
Change position every 2-3 hours.
Maintain skin hygiene and avoid maceration.
Change incontinence protection regularly.
Ensure sufficient and appropriate diet.
Drink regularly and sufficiently.
Avoid unnecessary thickness or foreign objects between body and support.

Notify Your Doctor or Nurse

Of any abnormal event (fever, pain, redness, whitening of support points).
If required measures for device use cannot be observed.

System Indicators and CPR Function

Indicator Lights

On: Indicates the compressor is switched on.
Flashing: Indicates inflation of the support. Patient can be placed after switch-off.
Locking System: Indicator light on means keypad is locked (after 5 min inactivity or 4 sec press). Unlock with a continuous 4-second press.
Care Mode (Static): Mode duration limited to 30 minutes. Indicator flashes 5 minutes before end, with an audible signal. After 30 mins, it reverts to the previously used mode.
Fixed LED: Low priority alarm. Contact maintenance.
Flashing LED: Medium priority alarm. Remove patient. Contact maintenance.
Moderate Alarm: Reactivation after 3 minutes. Press button to stop sound alarm.

Refer to the Technical Manual (downloadable from www.winncare.com).

CPR Function

Emergency CPR Opening: Depends on mattress type. Warning: Position must be closed during use.

Quick Deflation CPR: Less than 20 seconds.

Diagram Description: Illustrations show the CPR function for different mattress models (One Plus/Automorpho Plus, Axensor AT12/AT15, Axensor AT20/XXL), detailing quick deflation and inflation/deflation mechanisms.

Lateral Cable Pass: Standard on Automorpho Plus, AT20, and XXL mattresses. Available as an option on other models, except One Plus.

Safety, Compliance, and Environmental Conditions

Safety Symbols and Compliance

Caution: Read instruction for use and/or technical manual.
Category II Device: Dual insulation.
BF Type Electrical Device: Applied to supports.
Compliance: Meets general requirements of Medical Devices Regulation (EU) 2017/745.
Waste Disposal: Electrical and electronic equipment subject to selective waste collection.

Manufacturer: WINNCARE France

Serial Number, LOT, Batch Number, UDI: Provided on the device.

IP Rating: IP42 protection class according to IEC 60529.

Washing and Care Instructions

Top Cover Only: Machine wash at max 90°C, reduced mechanical action, reduced rinsing temperature, reduced spinning.
Complete Mattress (Machine Washable): Moderate wash up to 65°C.
Complete Mattress and Cover (Machine Washable): Tumble dry on low heat, moderate temperatures (60°C).
Chlorine Concentration: Maximum allowable 5000 ppm.
Ironing: Do not iron.
Dry Cleaning: Do not dry clean.

Environmental Conditions

Use Conditions

Temperature: +15°C to +40°C (+59°F to +104°F).
Humidity: 30% to 95%.
Maximum Altitude: ≤ 2000 m.

Storage Conditions

Temperature: -25°C to +70°C (-13°F to +158°F).
Humidity: 30% to 95%.
Atmospheric Pressure: 50 kPa to 106 kPa (7.25 Psi to 15.37 Psi).

Patient Weight Specifications

Specifications vary by model, including maximum patient weight and pressure settings (e.g., 165 kg / 364 lb max, 180 kg / 397 lb max).

Axtair APC Specifics

Specific information on the APC cushion is provided below. Refer to other sections for general information.

Model Codes: VAXT6/CO/AUTO, VAXT6/POMPE/AUTO-S.

Alternating Cycle Frequency: 1 cell out of 2.

Diagram Description: Illustration of the Axtair APC compressor unit, showing its compact size (10 cm), weight (4.2 kg / 9.2 lb), noise level (<35 dBA), IP rating (IP42), and dynamic mode capability.

Medical Device Composition (APC)