– Do not touch the patient and the docking contacts simultaneously.
– This product contains lithium-ion batteries which bear risk of fire, explosion and burns.
Do not disassemble, crash, heat above 100 °C (212 °F), incinerate or dispose of in fire.
– Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, walki-talkie can affect the Thopaz +
and should be kept at least a distance 30 cm away from the equip ment.
– HF (high-frequency) surgical equipment, radio networks or the like can influence the
operation of the device and may not be operated in combination with the Thopaz + .
CAUTIONS
– No modification of this equipment is allowed.
– Before connecting Thopaz + to the power supply, please verify that the supply voltage
corresponds to that given on the device specification plate.
– Incorrect use of Thopaz + can cause pain and injury to the patient.
– Do not use sterile accessories when the sterile packaging is damaged.
– Non sterile and reusable accessories must be cleaned and disinfected according to
chapter 13 – General cleaning guidelines.
– For the initial startup do not switch Thopaz + on before first charging the battery.
– The Thopaz + 2 l canisters are not intended for portable use (not by hand and not using
the carrying strap).
– For safety reasons canister changes within the appropriate fluid level shall be recorded.
– Before diagnosing controll detected fluid value for plausability.
– For patients for whom a breakdown of the device can lead to a critical situation a
replacement device must always be available.
Safety related tip
– Never place Thopaz + with an attached 2 l canister on the docking station without
attaching the optional adapter docking station 079.0038 for Thopaz + 2 l canister first.
– The acoustic alarm "Leak in system – 301" is deactivated for approximately 6 minutes
after Thopaz + is switched on.
– Everytime a new patient is connected, it is recommended to carry out the functional
check.
– Before the first application in accordance with the intended use, an inspection
according to IEC 62353 (see Appendix B) is recommended to acquire the reference
values.
– Medela recommends to use the biggest possible connector size compatible for
the catheter.
– Use sample port of tubing to drain a sample. Therefore refer to chapter 11 – Taking a
drainage sample.
Warnings and safety instructions
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