Lower Leg Cuff multi-use

Organization name

HILOTHERM GmbH

SRN

DE-MF-000006176

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• CW010

  Die Gebrauchsanweisung der Hilotherm Geräte muss beachtet werden.
• CW999

  Apply only to intact skin
• CW999

  Check for leaks before each application

Primary placement in Germany; available across 32 countries total.

Trade name

Lower Leg Cuff multi-use

UDI-DI code

04250387100701

Basic UDI-DI

42503871MANMMGF

Reference / catalog number

16000015

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The cuff may only be used with Hilotherm Clinic, Professionell • Follow the device instructions. • Check the cuff for damage (no bubbles, no leaks) before use. • Stop treatment immediately if leaks or blisters occur. • Avoid damage from sharp objects. • Do not fold or press the cuff – this blocks water flow. • Monitor patient’s body temperature regularly. • Use only on healthy skin or wound dressings. • Material discoloration is normal, not a defect. • Caution: Water may leak when connecting/disconnecting. Clean and disinfect manually after each use with approved clinic disinfectants (see www.rki.de). Wipe smooth surfaces; wipe or spray fabric-like areas (blue). Qualified staff must perform disinfection. Polyurethane is compatible with most disinfectants – follow manufacturer instructions. Cuff can be reused up to 10 times if properly cleaned. After cleaning, inspect visually and test for leaks using the device. Replace cuff if film, hoses, or connectors are damaged or worn. The operator is responsible for proper cleaning and testing. Hilotherm GmbH Wittumweg 38, D-88260 Argenbühl-Eisenharz, Tel. 07566 91199, www.hilotherapie.com

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 34–36 MU10
• 50–52 MU10

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification