Warnings and Cautions¶
Read and practice the following general warnings and cautions when you use the CapiScope HVCS.
General Warnings and Cautions¶
Do not attempt to operate the CapiScope HVCS until you have read and thoroughly understood the directions and warnings in this user manual.
Warnings¶
A warning statement in this manual identifies a condition or practice, which if not discontinued or immediately, could lead to injury, illness, or death.
Warning
To ensure safe operation of the CapiScope HVCS, you must place the CapiScope HVCS Probe Cover on the probe before applying the probe to tissue.
To avoid exposure to biohazardous material, adhere to standard protection from blood-borne pathogen exposure procedures, including the following:
Warning
Do not touch the HVCS and the patient simultaneously without the Probe Cover fitted.
Warning
Risk of explosion. Do not use the CapiScope HVCS in the presence of flammable liquids or gases, including flammable anaesthetics.
Warning
If you apply the probe to live tissue, do NOT exert excessive pressure. If you do, tissue damage may result.
Warning
Medical professionals should never make a diagnosis based solely on the CapiScope HVCS images.
Warning
High energy concentrated light. Do not look directly into the light source.
Warning
This product has no user serviceable or replaceable parts except for the probe lens and probe cover. Repairs made by anyone other than KK Research Technology Limited certified individuals will void the product warranty.
Warning
No modification of this equipment is allowed.
Warning
The USB port output connector must ONLYbe connected to a battery powered notebook computer with no other wired connections to any other device. The laptop computer must only be ever powered from a mains supply using a IEC 60601-1 certified power supply.
Warning
This equipment is intended for use by healthcare professionals only. This equipment may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the CapiScope HVCS or shielding the location.
Cautions¶
A caution statement in this manual identifies a condition or practice, which if not discontinued or immediately, could lead to equipment failure, equipment damage, or data loss.
Note
In order to obtain optimum performance and to ensure patient safety, thoroughly read this document.
Note
Never grab the probe by its objective (probe tip).
Note
Never use if you notice any signs of damage to any components of the system.
Note
Do not attempt to disinfect the CapiScope HVCS with glutaraldehyde products, ethelyne oxide gas, steam, or any other liquid or gas disinfectant.
Note
This product complies with current required standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices. As a precaution, avoid using this device in close proximity to other devices.
Probe Cover Warnings and Cautions¶
Warnings¶
Warning
Do not reuse the Probe Cover. Reuse could result in patient infection. Dispose of used Probe Covers in biohazard containers.
Warning
It is unsafe to operate the CapiScope HVCS without a Probe Cover. To ensure safe operation, you must check for the presence of the Probe Cover before you use the probe.
Warning
Do not make contact with the patient whilst changing Probe Covers.
Warning
If the Probe Cover package is open or damaged, do NOT use that Probe Cover. Dispose of it and obtain a replacement.
Warning
Always inspect the Probe Cover before use. If the Probe Cover is disfigured or broken, if it has a sharp edge, or if it has any type of noticeable damage, do NOT use it. Dispose of it properly and install a new Probe Cover on the probe.
Warning
Maximum duration of Probe Cover contact with patient is 60 minutes.
Cautions¶
Note
Install the Probe Cover securely to minimize the chances of accidental dislodging.
