LABORIE Goby Owner’s Manual GOBY-UM02 6
1.6 WARNINGS AND PRECAUTIONS
PRECAUTIONS
:
1. LABORIE equipment and accessories are licensed by Governments, approved by Safety Agencies and warranted
to work only with each other.
2. Do not exceed the maximum load marked on the adjustable shelf of 2 kg and the static shelf of 10kg.
CAUTION:
UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE OR USE BY OR ON THE ORDER OF A LICENSED
PHYSICIAN.
SYSTEM WARNINGS
:
READ CAREFULLY BEFORE USE!
1. DO NOT USE in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
2. DO NOT USE electromyography (EMG) simultaneously with high frequency surgical equipment.
3. DO NOT operate the Goby System near shortwave or microwave therapy equipment as proximity may produce
instability in the APPLIED PARTS.
4. DO NOT allow applied parts linked to a PATIENT CONNECTION, but no connected to the PATIENT, to contact
other conductive parts including those connected to protective earth. Preserve the patient connection electrical
isolation.
5. DO NOT place your fingers inside the pump head when the pump rollers are moving.
6. DO NOT USE the Goby™ in the presence of a magnetic resonance imaging system as it may contain
ferromagnetic objects that pose a risk to the patient in the presence of a magnetic core. The strong magnetic
field produced by the MRI may cause disruption of the system.
7. DO NOT ATTEMPT TO OPEN OR REPAIR the Goby™ system components by yourself or by an unauthorized
party. ONLY LABORIE-trained technicians may service the
Goby™ system components.
8. Do not clean or service the Goby™ System or components while in use with a patient.
9. Batteries are not operator removable; do not attempt to remove batteries from the Goby™ system components.
All servicing of
Goby™ system, components or attachments to be completed by LABORIE.
10. Exposure to ESD may cause the system to RESET.
11. LABORIE is not responsible for loss of patient files or test data. LABORIE is strongly recommended to back up
patient data on a regular basis.
12. Ensure all castor wheels are locked during testing procedures to prevent injury to the patient. DO NOT lean
anywhere on the system or its devices. The devices are not designed to support the weight of a person.
13. To prevent possible injury to the patient, always use the UPP puller with the UPP puller adaptor.
14. Re-use, reprocessing or re-sterilization of disposables can lead to device failure and create a risk of cross-infection
and/or cross transmission of infectious disease(s) from one patient to another.
15. DO NOT immerse the Goby™ equipment or any components in water or any other liquids.
16. Always position the Goby™ to facilitate ease of access to all electrical connections and plugs. The device
operator must be able to disconnect the device in case of emergency quickly and safely.
17. To avoid the risk of electric shock, only connect this equipment to supply mains with protective earth.
18. Only connect devices specified and approved by LABORIE to Goby™ multiple socket outlets. Connecting any
device not approved by LABORIE to the ME system alters the functional integrity of the product creating a safety
risk.
19. Avoid altering or adding to the Goby™ medical electrical system. Any alteration to the Goby™ system by an
unauthorized party transfers responsibility for meeting ME system requirements from LABORIE to the altering
party. Anyone connecting supplementary equipment to medical electrical equipment configures a medical
system and is therefore responsible for ensuring that the system complies with the requirements for medical
electrical systems, encompassed in the IEC 60601 series.
20. Do not place the printer in the patient environment unless it is powered via the LABORIE provided Line Isolation
Transformer (Separating transformer).
21. Only connect items that have been approved by LABORIE to the system. Any additional connections become the
responsibility of the operator and require testing to meet the IEC 60601-1, ME SYSTEMS requirements.
22. There is the risk of electrical shock if the operator plugs in non-ME Equipment (i.e. printer or laptop) directly into
the MAINS supply that is intended to be powered by a Line Isolation Transformer (Separating transformer).
23. Do not touch the printer/laptop and the patient simultaneously.
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