Table of Contents
Advertisement
Ignition of Flammable Anesthetic Mixtures
The console is not category AP or APG equipment and must not be used in oxygen-rich environments or envi-
ronments where flammable anesthetic gas mixtures are present.
Electrical Hazards
This equipment has been tested and found to comply with the EMC limits of the international standard IEC
60601-1-2. These limits are designed to provide reasonable protection against interference in a typical medical
installation. The equipment can radiate radio frequency energy if not installed in accordance with the instruc-
tions, and may cause harmful interference to other devices in the vicinity. There is no guarantee that interfer-
ence will not occur in a particular installation. Always comply with the following:
•
To avoid the risk of electrical shock, do not remove any panels of the product.
•
Refer servicing to qualified personnel.
•
Never operate equipment with damaged power line cords.
The Thermogard XP requires special precautions regarding EMC and needs to be installed and put into service
according to EMC information provided in this manual.
Portable and mobile RF communications equipment can affect the Thermogard XP.
Caution. Dangerous Voltage. Electric shock hazard. Always turn off the console and disconnect the power
line cord from the source before performing any service or maintenance procedures, or before moving the
console.To avoid the risk of electric shock, this equipment must be connected to a supply mains with protec-
tive earth.
WARNING. The potential equalization conductor should be connected to the potential equalization bus bar of
the electrical installation when available. Refer to the requirements in the IEC 60601-1 standard.
Primary Patient Temperature Probe (T1) Failure
The console relies upon the patient temperature reading from an YSI-400 type thermistor connected to the pri-
mary patient temperature probe (T1). There are rare failures of this type of thermistor that cannot be detected
by the console with 100% reliability. Failure of the T1 can result in either patient hypo- or hyper- thermia.
Death or serious injury to the patient may result. A secondary patient temperature probe (T2) connection is
therefore built into the console. For patient safety, either use both the T1 and T2 connections or employ the T1
probe with an independent frequent check of patient core temperature.
WARNING. Never clinically use a resistor in place of the T1 temperature probe. ZOLL supplies fixed
value resistors and variable resistor test boxes (e.g the TP-400 FOGG Box) for testing, training and demonstra-
tion purposes. These can be plugged into the primary patient temperature probe T1 connection on the front of
the console to represent a patient. Never use this device, or other method, to circumvent the normal patient
temperature feedback control when the console is connected to the patient. Doing so exposes the patient to
the hazards associated with hypo- or hyper- thermia. Death or serious injury may result.
Configuration Changes
WARNING. No modification of this equipment is allowed.
Caution. Certification requirements for external equipment connected to the console interfaces.
Equipment connected to the analog and digital interfaces must be certified to the respective IEC standards
(i.e., IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all con-
figurations shall comply with the console standard IEC 60601-1. Any person who connects additional equip-
8
Advertisement
Table of Contents
Troubleshooting
