Indications and contra-indications
Intended purpose of the Celsius TCS Hyperthermia System is the loco-regional overwarming of body volume particularly with regards to treatment of solid tumours.
Concomitant loco-regional hyperthermic warming induced by the Celsius TCS Hyperthermia System may support and/or complement the effects of conventional cancer treatment methods like radio- and/or chemotherapy. The device is intended to be used as far as local regional hyperthermic warming up of organs up to 42.0°C is the treatment of choice in addition to radio- and/or chemotherapy.
The following contraindications are described:
- Pregnant patients
There are no analyses of the mode of action of hyperthermia in pregnant women. An exclusion is necessary at all times, as the risks to both the embryo and pregnant women are not known.
- Metal implants
Patients with metal hip or knee implants and/or screws, with ingrown metal splinters or balls or with metal teeth implants could suffer burns near the metal implants, as metals, in particular, heat up excessively under the influence of energetic radio waves. Hence, tumour position, region, and logo-regional deep hyperthermia need to be taken into account.
Ask about pacemakers and similar electrodes as one cannot rule out the possibility of damaging the electronics of the pacemaker and thus causing malfunctions.
- Disturbed perception of temperature
Patients exhibiting a disturbed perception of temperature (e.g. after a stroke or pain drug intake) require special attention. The overheated areas need to be watched continuously (e.g. avoid accumulations of perspiration: can cause burn blisters and generally affect the circulation and comfort of the patient).
- Unstable cardiovascular system
This is a relative contraindication as this form of therapy poses a relatively low burden on the entire system. Nevertheless, patients with an unstable cardiovascular system need to be watched especially closely (RR measurements), since the cardiovascular system can be more unstable (lower) when sitting up following treatment.
- Patients with a bone marrow or stem cell transplant
Treatment with the Celsius TCS device must not be used in patients who have had bone marrow transplants.
- Open wounds
Patients with open wounds in the treatment area must not be treated.
- Scar tissue, damaged skin
Energy absorption in the subcutaneous fatty tissue during localized hyperthermia can result in fatty tissue burns or fatty tissue fibrosis. Localized cooling or pain therapy is usually sufficient.
Continuous supervision is required for patients with epilepsy, since an epileptic seizure can also not be excluded during the hyperthermia session.
- Patients under anesthesia
Patients under anesthesia may not be treated under any circumstances. A sedated patient has a significantly reduced pain perception. As a rule, the patient should be responsive and continuously monitored by trained professionals. The therapy recommendations can be used to support complementary therapies.