Device Description: WEYER CERAMOTHERM 1000 Radiant Warmer
The WEYER CERAMOTHERM 1000 is a radiant warmer designed to maintain the body temperature of patients, particularly infants and children, during various medical procedures such as postnatal care, baby changing, examinations, treatments, and pre-warming of patient beds. This device is suitable for continuous operation and adheres to the "Particular requirements for the safety of infant radiant warmers EN 60601-2-21".
Function Description
The CERAMOTHERM 1000 generates long-wave infrared radiation energy, which is absorbed by the skin and converted into body heat. The radiation spectrum falls within the far non-visible infrared range, ensuring that the radiation energy does not injure the patient's eyes. The ceramic heating elements are designed to be durable, not scaling and unaffected by liquid splashes. For patient comfort and clear visibility, two dazzle-free light sources are integrated into the radiant warmer, which can be switched on as needed.
The device features an electronic control system that allows for precise selection of the radiation intensity emitted to the patient pad, displayed in mW/cm². This selected intensity is continuously shown on an LED-spot field display. The system is equipped with visual and audible alarms to alert users to system faults and power failures.
A key safety feature is the automatic reduction of radiation intensity. If the selected intensity exceeds 10 mW/cm² for more than 15 minutes, the intensity is automatically reduced to 10 mW/cm², and an alarm is triggered. This is crucial because radiation intensity above 10 mW/cm² can potentially lead to hyperthermia in infants. The operator can either reduce the intensity or confirm the high intensity for another 15 minutes by pressing a pushbutton. For specific applications where continuous high intensity is required and the patient's temperature is closely monitored (e.g., with a temperature monitor), this safety function can be temporarily switched off by a conscious action, confirmed by two short tones and a flashing yellow warning lamp. Reactivation of this function is also confirmed by a short tone. The safety function is always activated when the radiant warmer is switched on anew.
The intensity display does not provide information about the patient's body temperature, emphasizing the need for regular temperature checks or monitoring of the patient. The radiation intensity reaching the patient's skin is approximately 4 mW/cm² higher than the displayed value due to the shorter distance between the radiant warmer and the patient's body surface compared to the patient pad.
Usage Features
The CERAMOTHERM 1000 is designed for ease of use and safety.
Start-up: Only qualified personnel should install and start up the device and instruct users. Before operation, the device and its mount must be checked for secure positioning and proper function of any adjusting elements. A 9V battery, included with the device, must be installed in the compartment located on the bottom side of the warmer, next to the nameplate, to power the safety cut-off and alarm functions. The device should be cleaned in a cold condition before use.
Controls and Displays:
- Button Illumination On/Off (1): Controls the illumination of the patient area.
- Button Heating On/Off (2): Activates/deactivates the heating elements.
- Alarm Reset Button (4): Resets audible alarms for the >10 mW/cm² safety function or temporarily switches off this safety function for approximately 3 seconds.
- Pilot Lamps (5, 6, 11): Green lamps indicate illumination, heating power availability, and heating status (flashing for intensity selection).
- Warning Lamp (red) (7): Flashes for low battery capacity (below 10 minutes for power failure alarm) or lights continuously with a permanent alarm tone for power failure (interrupted power line).
- Warning Lamp (yellow) (10): Lights when intensity selection is above 10 mW/cm² (safety function activated) or flashes when the safety function is temporarily switched off.
- Intensity Selection Display (12): LED-spot field indicating the selected radiation intensity.
- Intensity Selection Knob (13): Allows selection of radiation intensity in 15 increments.
Operation:
- After switching on the light (1) and heating (2), a self-test is performed, accompanied by a tone and all displays lighting up for 2 seconds. Users should verify this.
- The desired radiation intensity is selected using knob (13), with the selection indicated on display (12).
- Heating-up time varies between 3 and 15 minutes, depending on the selected intensity and ambient temperature.
- For long-term care, radiation intensity must be selected with utmost care, especially for smaller, immature infants or in lower ambient temperatures, which increase heat demand. Initially, 10 mW/cm² is recommended for unclothed infants, with body temperature checked regularly.
- The maximum intensity reachable depends on the device model and calibrated distance, ranging from 14 to 30 mW/cm². If an unreachable selection is made, a flashing LED spot indicates this, and the intensity should be reduced.
Mounting Options: The CERAMOTHERM 1000 can be mounted in various configurations:
- Static Mounts: Ceiling mount, wall holder, and lateral wall holder. These provide a fixed distance to the patient pad.
- Flexible Mounts: Wall arms (320 mm, 480 mm, or 600 mm long) and double-joint wall arms allow for horizontal swiveling (180° or 360° rotation of warmer) and, with optional upgrades, vertical adjustment (±45°) and vertical extension.
- Height-Adjustable Mounts: Double-joint wall arms and double-joint ceiling arms offer adjustable distance to the patient pad, horizontal swiveling, and vertical adjustment. A safety distance of 650 mm between the bottom line of the radiant warmer and the patient pad must be maintained, mechanically secured if necessary.
- Mobile Radiant Warmers: Height-adjustable mobile stands with anti-static castors (2 with kickstops) allow for mobility, 360° rotation of the warmer, and vertical adjustment (±45°). The device must be moved in its lowest position, and the red distance mark on the stand should align with the patient pad level to ensure the calibrated safety distance of 650 mm.
Safety Considerations:
- The radiant warmer is not suitable for use in explosion-hazardous areas.
- Ambient conditions should not be influenced by other heating or air conditioning devices; a minimum distance of 1m should be maintained.
- The warmer should not be placed in draughts, near cold walls or windows, or in direct sunlight.
- No medical drugs, infusion fluids, or other items should be placed above or within the irradiated area of the warmer.
- A minimum distance of 50 cm must be maintained between the radiant warmer and any flammable material (e.g., curtains), considering the moving radius of adjustable mounts.
- The safety guard or top of the radiant warmer can reach temperatures above 85°C during operation, so touching these areas should be avoided, and infants/children must be prevented from gripping the safety guard.
- Dark metal items should not be placed within the radiation field as they can become dangerously hot.
- When using the warmer with a phototherapy device, increased patient temperature and humidity loss should be observed.
- The trans-epidermal humidity loss in patients under radiant warmers can increase unconsciously.
- Never use the radiant warmer with flammable anesthesia gas or other flammable materials/cleaning fluids (e.g., alcohol, ether).
- Never cover the radiant warmer while it is warm, as this impairs convection.
Maintenance Features
To ensure the safe operation and longevity of the CERAMOTHERM 1000, regular maintenance is recommended.
- Annual Inspection: A yearly inspection by qualified persons is recommended to verify conformance with normal use, check the general condition of the device, secure position of mounts, function and secure fixing of adjusting facilities, possible damages, device functions, safety provisions, and electrical safety measurements according to national standards.
- Preventive Maintenance: In addition to the annual inspection, preventive maintenance by qualified persons is recommended to maintain the nominal state. This includes checking interior wiring, connections, heating elements, and all safety-relevant parameters according to IEC 601-2 and EN-60601-2-21.
- Battery Replacement: The 9V battery for the power failure alarm should be changed by qualified persons once per year, or at the latest, when the warning lamp (7) flashes during operation.
- Cleaning and Disinfection: The radiant warmer should be cleaned and disinfected for every new patient, or at least once per week.
- After use, switch off the warmer, allow it to cool, and disconnect the power plug.
- Clean the device with a cloth slightly saturated with a recommended cleaning agent and wipe dry.
- No liquid must enter the top of the device housing.
- Important: The ceramic heating elements must not be treated with cleaning agents or disinfectants.
- After disinfection, allow the radiant warmer to dry for at least 1 hour; do not switch it on to accelerate drying.
- After cleaning and disinfection, check all functions.
- Responsibility: The manufacturer is only responsible for the safety features of the device when maintenance is carried out by qualified persons, following instructions and using original spare parts.
- Pre-Maintenance Cleaning: Devices or components must be cleaned and disinfected before any maintenance measure or before being sent to the factory for repair.
Waste Disposal:
- Fluorescent tubes and batteries are classified as hazardous waste and must be disposed of accordingly.
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