Sanitas SFT 08 - Thermometer Manual

Table of Contents

Contents

1 Signs and symbols
2 Included in delivery
3 Important safety information – retain for later use
4 Memory
5 Changing the measuring unit
6 Changing the battery
7 Notes on handling batteries
8 Cleaning/Disinfection
9 Storage/Disposal
10 Technical data
11 Electromagnetic Compatibility Information
12 Documents / Resources
- 12.1 Download manual

Signs and symbols

The following symbols are used in these instructions for use, on the packaging and on the type plate for the device and accessories:

	Caution
	Follow instructions for use
	Type BF applied part
	Disposal in accordance with EC Directive WEEE (Waste Electrical and Electronic Equipment)
	Manufacturer
IP 27	Protected against foreign objects equal to or greater than 12.5 mm and against temporary immersion in water.
	Batch designation
Storage		Permissible transport and storage temperature. Permissible transport and storage humidity.
Operating		Permissible operating temperature and humidity
		The CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical products.

Included in delivery

Thermometer
Instruction for Use

Important safety information – retain for later use

In order to make optimum use of all the merits of the clinical thermo meter, you should carefully read the operating instructions before using it, retain the instructions for later use and also keep them accessible for other users.

The thermometer is intended to measure the temperature of the human body.
The thermometer is only designed for the measuring area on the human body stated in the instructions for use.
Children should not use the thermometer without supervision.
Before each use, check the thermometer for signs of damage or wear. Damaged or worn thermometers should not be used.
Always wait for the acoustic signal which indicates the minimum time required for measurement. Discuss the temperature with your family physician.
The thermometer contains sensitive electronic parts. Therefore, protect it from blows, bending, high temperature or direct exposure to sunlight.
Using the thermometer in strong electromagnetic fields such as next to a mobile phone, can cause a malfunction.
This thermometer has a flexible measuring tip to provide greater comfort and safety during measurement, particularly in infants and persons who are asleep or have a reduced level of consciousness. The tip must not be bent more than 90°!
When the thermometer is switched on, it carries out a self-test. Therefore the accuracy of measurement need not be tested at regular intervals.
If the temperature is very abnormal, please contact your family doctor promptly.
This device meets the requirements of the EU Directive 93/42/EEC concerning medical devices, as well as those of the Medizinproduktegesetz (German Medical Devices Act), the European Standard EN 12470-3: Clinical thermometers – part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device and the European Standard EN60601-1-2, and is subject to particular precautions with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this unit. More details can be requested from the stated Customer Service address or found at the end of the instructions for use.

when a stable temperature has been reached. When this stage has been reached, an acoustic signal is heard, the "°C" ("°F") symbol stops flashing and the temperature measured is displayed. As long as the measured temperature is below 32°C (89,6°F), "Lo °C" ("Lo °F") will appear. Higher temperatures will be shown directly, e.g. 32,1°C (89,8°F). By prolonging the length of measurement until after the acoustic signal, more ac curate measurements can be obtained. In case the temperature is measured in the armpit, the thermometer should be left in the armpit for the recommended time of measurement, in spite of the acoustic signal. If temperatures over 37,8°C (100°F) are measured, a fever alarm sounds (short bleeping tones, 10 seconds long). If temperatures higher than 42,9°C (109,2°F) are measured, the symbol for "Hi °C" ("Hi °F") will appear. To prolong the life of the battery, please switch off the thermometer by briefly pressing the on/off key after the measurement. Otherwise the thermometer will automatically switch off after 10 minutes.

Memory

The last measured value will be stored automatically. Press the ON/OFF button to display this value. The thermometer first carries out a self test. Next the last stored measured value is displayed for approx. 2 sec and then the reference value of 37°C (98,6°F) and "Lo" is shown on the display. The thermometer is ready to take a measurement and the previously stored measurement value is automatically replaced by the new measurement value.

Changing the measuring unit

The temperature can be displayed in degrees Celsius (°C) and degrees Fahrenheit (°F). To set the measuring unit press and hold the On/Off button for longer than 2 seconds when switching on until the measuring unit changes.
The saved value is displayed in the new measuring unit.

Changing the battery

The clinical thermometer contains a long-lasting alkali-manganese battery (type LR 41, 1.5 V) for approximately 2 years. The battery has to be replaced when appears in the bottom right corner of the display. Release the battery compartment cover by gently pressing on the catch. Remove the old battery and replace it with a battery of the same type. The + sign on the battery must point upwards. Then close the battery compartment, making sure that the catch clicks into place. The empty, completely flat batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries.
The codes below are printed on batteries containing harmful substances: Pb = Battery contains lead, Cd = Battery contains cadmium, Hg = Battery contains mercury. These batteries contain lead (Pb) and mercury (Hg).

Notes on handling batteries

warning

If your skin or eyes come into contact with battery fluid, flush out the affected areas with water and seek medical assistance.
Choking hazard! Small children may swallow and choke on batteries. Store the batteries out of the reach of small children.
Observe the plus (+) and minus (-) polarity signs.
If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
Protect the batteries from excessive heat.
Risk of explosion! Never throw batteries into a fire.
Do not charge or short-circuit batteries.
If the device is not to be used for a long period, take the batteries out of the battery compartment.
Use identical or equivalent battery types only.
Always replace all batteries at the same time.
Do not use rechargeable batteries.
Do not disassemble, split or crush the batteries.

Cleaning/Disinfection

The device must be cleaned and disinfected before and after each use. The thermometer is 100% water-proof. For the purpose of cleaning or disinfection, it can be dipped into water or disinfectant without any difficulties. Under no circumstances should the thermometer be boiled! Use one of the following disinfectants in accordance with the manufacturer's instructions. Other cleaning agents or methods could impair the function of the thermometer or damage it.
Name of the agent: Isopropanol 70% Pharmacy; Gigasept FF; Lysoformin; Aseptisol.

Storage/Disposal

When you are not using the thermometer, please retain it in the original protective cover.
The accuracy of this thermometer has been carefully checked and developed with regard to a long useful life.
If using the device for commercial medical purposes, it must be regularly tested for accuracy by appropriate means. Precise instructions for checking accuracy may be requested from the service address.
For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the unit at a suitable local collection or recycling point. Dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities responsible for waste disposal.

Technical data

Type	SFT 08
Range of measurement	32°C (89,6°F) to 42,9°C (109,2°F)
Accuracy of measurement	± 0.1°C in a water bath with a temperature of 35,5°C (95,9°F) to 42,0°C (107,6°F) ± 0.2°C in a water bath with a temperature of 32,0°C (89,6°F) to 35,4°C (95,7°F) ± 0.2°C in a water bath with a temperature of 42,1°C (107,8°F) to 42,9°C (109,2°F)
Ambient temperature	+5°C – +40°C (41°F – 104°F), with 15% to 95% relative humidity
Storage temperature	-20°C – +55°C (-4°F – 131°F), with 15% to 95% relative humidity

Subject to errors and changes

Electromagnetic Compatibility Information

Table 1

Guidance and manufacturer's declaration – electromagnetic emissions
The SFT 08 is intended for use in the electromagnetic environment specified below. The customer or the user of the SFT 08 should assure that it is used in such an environment.
Emissions test	Compliance	Electromagnetic environment – guidance
RF emissions CISPR 11	Group 1	The SFT 08 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11	Class B	The SFT 08 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2	Not applicable
Voltage fluctuations / flicker emissions IEC 61000-3-3	Not applicable

Table 2

Guidance and manufacturer's declaration – electromagnetic immunity
The SFT 08 is intended for use in the electromagnetic environment specified below. The customer or the user of the SFT 08 should assure that it is used in such an environment.
Immunity test	IEC 60601 test level	Compliance level	Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6	3 Vrms 150 kHz to 80 MHz	Not applicable	Portable and mobile RF communications equipment should be used no closer to any part of the SFT 08, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1,2 d = 1,2 80 MHz to 800 MHz d = 2,3 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, ^a should be less than the compliance level in each frequency range ^b. Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF IEC 61000-4-3	3 V/m 80 MHz to 2,5 GHz	3 V/m
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SFT 08 is used exceeds the applicable RF compliance level above, the SFT 08 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SFT 08. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table 3

Guidance and manufacturer's declaration – electromagnetic immunity
The SFT 08 is intended for use in the electromagnetic environment specified below. The customer or the user of the SFT 08 should assure that it is used in such an environment.
Immunity test	IEC 60601 test level	Compliance level	Electromagnetic environment – guidance
Electrostatic discharge (ESD) IEC 61000-4-2	6 kV contact 8 kV air	6 kV contact 8 kV air	Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4	2 kV for power supply lines 1 kV for input/output lines	Not applicable	Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5	1 kV line(s) to line(s) 2 kV line(s) to earth	Not applicable	Mains power quality should be that of a typical commercial or hospital environment.
interruptions and voltage variations on power supply input lines IEC 61000-4-11	< 5% UT (> 95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles < 5% UT (> 95% dip in UT) for 5 sec	Not applicable	Mains power quality should be that of a typical commercial or hospital environment. If the user of the SFT 08 requires continued operation during power mains interruptions, it is recommended that the SFT 08 be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8	3 A/m, 50/60Hz	3 A/m	Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE U_T is the a.c. mains voltage prior to application of the test level.

Table 4

Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM
The SFT 08 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SFT 08 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SFT 08 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W)	Separation distance according to frequency of transmitter (m)
Rated maximum output power of transmitter (W)	150 kHz to 80 MHz d = 1,2	80 MHz to 800 MHz d = 1,2	800 MHz to 2,5 GHz d = 2,3
0,01	0,12	0,12	0,23
0,1	0,38	0,38	0,73
1	1,2	1,2	2,3
10	3,8	3,8	7,3
100	12	12	23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.