Ablation device,thermal,handheld,model 3

GENERAL DESCRIPTION
Thermal ablation device (thermo-coagulator), battery operated, including 4 probes.

MANUFACTURER / MODEL
Manufacturer: WISAP Medical Technology GmbH.
Country of manufacture: Germany.
Model name: C3 EC04

INTENDED USE
A thermal ablation device is a self-contained, electrically powered medical instrument designed to destroy tissue of the uterine cervix with low-grade heat. This portable device uses a reusable probe which is electrically heated to approximately 100° Celsius and applied for a period of 20 – 30 seconds to the affected area. This will result in epithelial and stromal destruction of the lesion. It may also be referred to as thermal coagulation or Semm cold coagulation, after the inventor of the device. The term “cold” has been used due to a treatment temperature of 100°C, which is lower than that used for standard clinical electrocautery (usually between 400-600°C).

TECHNICAL SPECIFICATIONS
Probe tip temperature is controlled to reach 100°C ± 10°C and not surpass required temperature.
Audible cues provide feedback to user to ensure working temperature reached.
Audible feedback indicates time has elapsed, user to terminate the heating.
Device is simple and easy to use, appropriate for all levels of care.
Device features built-in full spectrum light source for viewing and assessing the cervix.
The device is portable and lightweight, easily carried in a case or backpack, together with all its accessories.
The device comes with a hard case for storage purposes and to protect the device during transport.
Comes with 4 probes:
- 2 x flat probe 20 mm
- 1 x flat probe 17 mm
- 1 x probe with a nipple extrusion, 20 mm.
Probes do not have sharp edges, are made from biocompatible material that will not adhere to cervix and are removable and reusable.
The shaft and tips can be decontaminated between uses by High Level Disinfection. Consult user instructions for details on decontamination procedures.
Comes with a single battery, a power adapter, and cables to charge from the power adaptor or from a 12 Volt car outlet.
The number of consecutive ablation treatments with a fully charged battery is approximately 100. The number of treatments can vary depending on the environmental temperature, the time in between heating cycles, and the number of burns during a single treatment.
The batteries are rechargeable with a capacity of approximately 75.5 Wh.
Units come with a charger, suitable for a mains power supply in the range of 110-220 V, 50-60 Hz power.

SUPPLIED WITH
Instructions for use in English.
- 1 x storage case
- 2 x flat probe 20 mm
- 1 x flat probe 17 mm
- 1 x probe with a nipple extrusion, 20 mm

OPTIONAL ITEMS ADDED AT COST
Additional probes:
- 17 mm flat
- 20 mm flat
- 20 mm nipple
Additional batteries

LIFE SPAN
Probes: 300 use-disinfection cycles
Handle: Minimum 3 years.

WARRANTY
Two years warranty after shipment excluding the battery and probes.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 10°C - 40°C / ≤ 85 % RH
- Storage conditions: 10°C - 50°C / ≤ 85 % RH
- Atmospheric pressure: 700 – 1060 hPa
- IP Rating:
- Handle: IPX0
- Probes: IPX7

WEIGHT AND VOLUME (packaged)
Weight: 3 kg
Volume: 26.64 dm3

ESTIMATED DELIVERY LEAD TIME
Three weeks.

MINIMUM ORDER QUANTITY
5 pieces

INSTALLATION REQUIREMENTS
There is no need for a qualified technician to assemble or commission this device.

TRAINING REQUIREMENTS
Should only be used by trained medical professionals.

MAINTENANCE/USER REQUIREMENTS
As per user manuals.

COMPONENT OF A KIT
No part of a kit.

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.

CLASSIFICATION
CE certified as class IIa device under MDD 93/42/EEC.

SAFETY & PRODUCT STANDARDS
Compliant with active version of the following standards for General Manufacturing (or equivalent):
- ISO 14971: Medical Devices - Application of Risk Management to Medical Devices.
- ISO 15223-1: Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements.
- IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Please provide the relevant certification or test report.
- IEC 60601-1-2: Medical electrical equipment - Part 1-2 General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. Please provide the relevant certification or test report.
BATTERY
- IEC 62133 - Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells: Part 1: Nickel Part 2: Lithium.
PROBES
- ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process;