Safety Information; Notice To All Users; Contraindications; Biological Safety - Mcube CUBEscan BioCon-900S Operator's Manual

SAFETY INFORMATION

2

NOTICE TO ALL USERS

2.1
This guide covers components, function, maintenance, storage, and precautions needed to use this
system. All users must read and thoroughly understand this entire guide prior to using the BioCon-900S.
This section has information on safe use of the BioCon-900S (Biological Safety, Electrical Safety, Device
Safety and Safe handling procedures for transporter).
Complies with FDA performance standards for laser products except for deviations pursuant to Laser
Notice No. 50, dated June 24, 2007.

CONTRAINDICATIONS

2.2
WARNING
Do not use the BioCon-900S on following cases:
1) Fetal use or pregnant patients.
2) Patients with ascites.
3) Patients with open or damaged skin.
Wounds in the suprapubic region.

BIOLOGICAL SAFETY

2.3
To date, exposure to pulsed diagnostic ultrasound has not been shown to produce adverse effects.
However, ultrasound should be used only by medical professionals when clinically indicated, using the
lowest possible exposure times possible commensurate with clinical utility. The ultrasonic output power of
BioCon-900S is limited to the minimum level necessary for performance effectively. Data on acoustic
output levels is listed in section "9. Specifications".

ELECTRICAL SAFETY

2.4
This system meets IEC 60601-1, Class I, Type BF isolated patient-applied parts safety requirements. This
system complies with the applicable medical device requirements published in the Canadian Standards
Association (CSA), European Harmonized Standards, and Underwriters Laboratories (UL) safety
standards.
To avoid the risk of electrical shock or injury, observe the following warnings and cautions.
WARNING

To avoid the risk of electric shock, this device must only be connected to an adapter with the
protective earth. - Grounding reliability can only be achieved when device is connected to a
receptacle marked "Hospital Only" or "Hospital Grade" or the equivalent.

Do not operate the system in the presence of flammable gases or anesthetics.

Do not use the device with any defibrillator at the same time.

Do not use the device with any HF surgical equipment at the same time.

Before using the system, inspect the enclosures, power cord and adapter.Do not use the system if
these are damaged.

Do not use the probe if the entire probe is accidentally immersed in solution.

Connect only items that have been specified as part of the BioCon-900S or that have been specified
as being compatible with the BioCon-900S.

Charge the probe only with the provided Charger.

Connect the Charger only to the provided adapter.
TM
CUBEScan BioCon-900S Operator's Manual
Page 8