Hilotherapy Device HTP1with standard accessories

Organization name

HILOTHERM GmbH

SRN

DE-MF-000006176

Manufacturer status

Active

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

• CW999

  Before machine startup, the operator has to check if the device and the application parts are in a proper state. • The therapeutical system always consists of a Hilotherapy device, duo hose and cuff(s • Use and connect only the original Hilotherapy devices and cuffs. • The cuff must be removed if it cannot be used as intended because of a fault. • During treatment, especially when using several or large cuffs, the patient’s body temperature should be monitored • The Hilotherapy system must not be used within an incubator. • The cuffs may be damaged by sharp objects. • The proper flow through the cuff channels may be obstructed by folding or compressing the cuffs. • The flow through the tubing may be obstructed by kinks. • Only fill up the tank with demineralized water. • When filling up the tank with demineralized water, disconnect the device from the mains. • The panel ventilation slots must not be blocked or covered. The device may only be operated when positioned on a level and flat surface. • The device may only be used when all units and displays are working properly. • In case of failures, switch the device off immediately. Only after the failure condition was rectified, the machine may be used again. Please inform the manufacturer of any kind of critical or unclear errors. • Warning! It is not permitted to modify the device.
• CW999

  Warning: The device contains small parts (cap). Care should be taken that these are not inhaled or swallowed by infants or other persons. • Warning: Danger of strangulation with the connecting cables or power supply lines, especially for small children. The connection hoses and power supply lines must be laid in such a way that there is no danger of strangulation. The use in children must be adequately supervised.Do not open the housing. • Prior to maintenance, disconnect the device from power supply. • Maintenance must be carried out in accordance with the maintenance instructions. • The AC voltage source must comply with the data given on the type plate attached to the back of the machine

Primary placement in Germany; available across 32 countries total.

Trade name

Hilotherapy Device HTP1with standard accessories

UDI-DI code

04250387101647

Basic UDI-DI

42503871HTP1ProRX

Reference / catalog number

00100010

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Medical device providing continuous, controlled temperature therapy via circulating water through external applicators for pain management, edema reduction and tissue protection.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 21.5–23.5 MU10
• 24–26 MU10
• 25–27 MU10

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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