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Instructions for use, ERGO 300 - BOWA- IFU-12930- ERG0300-S0-EN-20210701
3.4
Essential requirements
Before using the ERGO 300 - Morcellator, this
instruction manual must be read thoroughly and
you must be well acquainted with the functions
and handling of the unit.
The products described in this manual must be
used by trained and qualified medical personnel
only in accordance with the requirements and
with reference to the manual.
For protection of the patient, the user and third
parties the products used must be prepared as
specified in the manual.
Improper use or repair of the device, or failure to
observe these instructions, will relieve us from
any obligation arising from warranty provisions or
other claims.
The use of third-party products is the
responsibility of the operator. Functionality and
patient safety cannot be guaranteed with third-
party accessories.
Prior to using the device, before startup,
and before operation, the user must always
ensure that the device and accessories are in
good working order and are clean, sterile and
operational.
Repairs may only be performed by authorized
NOUVAG service technicians.
Only use NouvaClean and NouvaOil spray to
care for the gear unit. For the electronic motor
use only NouvaOil spray. The use of other care
products can lead to malfunctions and void the
guarantee.
Uterine tissue may contain unsuspected cancerous tissue. The use of laparoscopic, motor-driven morcellators in
hysterectomy and myomectomy, carries the risk of spreading cancerous tissue beyond the uterus, thereby reducing long-
term patient survival. This information should be communicated to patients in advance of surgery when the use of motor-
driven morcellators is being considered.
3.5
During use
The device is not sterile on delivery. All sterilizable
parts must be sterilized before use (see Chapter 7
Instrument preparation).
Never operate the clamping mechanisms of the
cutting tubes while the system is running. This
could result in instrument damage.
Operate the device only outside the danger zone
of explosive, flammable mixtures or gases.
Keep hands clear of the cutting tubes when
operating the device. Danger of serious injury.
The motor ventilation slots must be kept clear in
order to prevent the motor from overheating.
The ERGO 300 - Morcellator must be operated
under the continuous supervision of medically
qualified persons only.
The risks and benefits of using recovery pouches
when using motor-driven morcellators in
laparoscopic procedures remain to be determined
and established.
Make sure that the operating voltage matches the
mains voltage.
Disregarding the guidelines on intermittent
operation (1 min on, 1 min off for 8 cycles) may
cause burns at contact with the gear unit.
