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Xenios DELTASTREAM HC, Instructions For Use Manual

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MARkINg AND SyMbOLS

MARkINg AND SyMbOLS

Catalog number 

Batch code

Manufacturer 

Date of manufacture 

Temperature limit 10-40 °C (50-104 °F) 

Keep away from sunlight 

Keep dry

Do not use if package is damaged 

Consult instructions for use 

Non sterile

Separate collection of 
electrical and electronic equipment

Summary of Contents for DELTASTREAM HC

Page 1: ...INSTRUCTIONS FOR USE DELTASTREAM HC...

Page 2: ...umber Batch code Manufacturer Date of manufacture Temperature limit 10 40 C 50 104 F Keep away from sunlight Keep dry Do not use if package is damaged Consult instructions for use Non sterile Separate...

Page 3: ...tion DISTRIBUTOR Xenios AG Im Zukunftspark 1 74076 Heilbronn Germany Phone 49 7131 2706 0 Fax 49 7131 2706 299 info xenios ag com www xenios ag com MANUFACTURER medos Medizintechnik AG Obere Steinfurt...

Page 4: ...unit or of personal injury if it is ignored The patient s life and health could also be at risk The following symbols are used in the text in order to clarify instructions Identifies lists Means actio...

Page 5: ...1 2 Setting up with the deltastream Trolley 11 4 2 Water quality 12 4 3 Connecting the deltastream heater cooler 12 4 3 1 Filling the system with water 12 4 3 2 Connecting the oxygenator 13 4 3 3 Elec...

Page 6: ...4 Power failure alarm 24 7 Cleaning and disinfection 25 7 1 Unit 25 7 1 1 Surface cleaning and disinfection 25 7 1 2 Changing water and disinfecting the water circuit 26 7 1 3 Disinfection 27 8 Mainte...

Page 7: ...tructions for use carefully and conscientiously 1 1 LIMITATION OF LIABILITY In this instruction manual all technical information data and instructions for installation operation care and servicing cor...

Page 8: ...o ensure patient safety the unit should be monitored continuously during operation The product may only be used on the instructions of a doctor under medical supervision and only by medically trained...

Page 9: ...3 The height difference between the unit and oxygenator must be 75 cm Do not cover the unit There are ventilation openings at the sides underneath and at the rear WARNING Pay attention to the automati...

Page 10: ...g or transport report this immediately to the shipper insurance company and the supplier 3 2 UNPACKING To unpack the unit Take the unit out of the box and remove the packaging material Place the unit...

Page 11: ...the floor The deltastream Trolley which is avail able as an accessory meets all these requirements If the unit is not horizontal the water indicator at the front will show the incorrect water level I...

Page 12: ...rst time please follow the instructions on disinfect ing see Maybe some of the listed prod ucts are not available in your country Take care about the availability on page 27 The system is a closed cir...

Page 13: ...ks into the coupling on the unit such that it cannot come loose The connections between the unit and the oxygenator are correct if the water flow meter rotates when the unit is switched on Before use...

Page 14: ...the unit fol low the instructions below when connecting the power Before switching on the unit compare the connec tion details voltage and frequency on the type plate with those of your mains electri...

Page 15: ...alue 4 Fault indicator 5 Water level gage 6 Temperature display for target value 7 Water flow rate indicator 8 Mains switch 9 Hose couplings 10 Thread for locking screw in base plate 11 Display for st...

Page 16: ...tream heater cooler unit are used to heat or cool the patient s blood between 15 C and 39 C with the aid of a oxygenator The temperature line between the patient s blood and the water circuit runs via...

Page 17: ...Disadvantages of therapeutic hypothermia include Extended bypass time from cooling to heating Increased blood viscosity with increasing degree and duration of organ damage and tendency to bleed 6 USE...

Page 18: ...nk see 4 3 1 Filling the system with water on page 12 to the MAX mark with sterile water Follow the instructions on disinfecting see 7 2 2 Chang ing water and disinfecting the water circuit on page 27...

Page 19: ...r more indicators are faulty In these cases have the unit checked by a Medos approved customer service 6 2 3 SETTING THE TEMPERATURE Use the two arrow keys 14 and 16 to set the target value for the wa...

Page 20: ...Checking the water flow rate Check the water flow in the unit and oxygenator at regular intervals There is an impeller in the viewing window of the water flow rate indicator 7 The individual impellers...

Page 21: ...fault This means that the operator is quickly informed of any faults thereby increasing the operating safety of the system The fault condition that triggered the alarm is shown on the display 11 with...

Page 22: ...eliably control the temperature After the unit has been switched on and after a change in the target tem perature value this alarm function is suppressed for a set time WATER LEVEL The unit triggers t...

Page 23: ...uence of steps described in this manual Otherwise the unit may be damaged If the unit continues to sound an alarm take it out of service and have it checked by an authorized service technician ALARM T...

Page 24: ...d could be damaged If the unit continues to sound an alarm take it out of service and have it checked by an authorized service technician CHECK UNIT CUSTOMER SERVICE The unit triggers this alarm if a...

Page 25: ...c PVC or PU As far as possible do not use disinfectants based on phenol derivatives because they shorten the life of plastics Please note the list of surface disinfec tants on this page 26 Make sure n...

Page 26: ...berculous my cobacteria and other germs After each therapy As part of the initial commissioning at latest 30 days after the start of therapy in case of storage and or prolonged non use generally after...

Page 27: ...tects disinfectant residues If the device continues to operate recharge it with sterile water until it is slightly below the MAX mark on the level gauge Stored devices must be disinfected every 30 day...

Page 28: ...ating safety and long life of the unit WARNING Do not use methods for cleaning and de contamination other than those recom mended by Medos Medizintechnik AG Check with Medos Medizintechnik AG before i...

Page 29: ...ng the protective conductor resistance and the earth current in accordance with the test equipment and the manufacturer s data Checking all functions as per the instruction manual Checking all safety...

Page 30: ...ing Replace O ring Valve on unconnected coupling drips constantly 1 Inner O ring damaged 2 Inner O ring dirty 1 Customer Service 2 Insert and remove coupling several times or contact Customer Service...

Page 31: ...unit until power is reinstated 2 Check plug is seated correctly in socket 3 Customer Service 4 Customer Service Switch off the unit immediately 10 DISPOSAL OF THE OLD UNIT Old electrical and electron...

Page 32: ...rox 750 W max at 27 C Cold output Approx 500 W max at 27 C Heat up time Approx 5 10 min 20 C 37 C Cool down time Approx 5 10 min 20 C 15 C Fuse rating 2 T 3 15 L 250 V 220 230 V 2 T 5A L 250 V 115 V P...

Page 33: ...2400 LT 1000 800 LT children and newborns HC coupling ME ZW05 0009 Water connection for hollow fiber oxygenator hilite 2800 2400 LT 1000 800 LT children and newborns HC 90 coupling ME ZW05 0010 Water...

Page 34: ...lectromagnetic environment guidelines HF emissions as per CISPR11 Group 1 The deltastream heater cooler units use HF power exclusively for their internal functions Its HF emissions are there fore very...

Page 35: ...for a typical com mercial or hospital environment Surges as per IEC 61000 4 5 1 kV external conductor external conductor 2 kV external conductor earth 1 kV 2 kV The quality of the supply voltage shoul...

Page 36: ...e distance in meters m The field strength of stationary radio transmitters should at all frequencies be a less than the compliance level as per a test performed on site and b no interference should be...

Page 37: ...ted output of transmitter W Safe distance as a factor of transmission frequency in m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 33 P 0 01 0 12 m 0 12 m 0 24 m 0 1 0 3...

Page 38: ...Press and hold Confirm key for temperatures above 38 C while pressing arrow keys at the same time Press and hold Confirm key for temperatures below 35 C while pressing arrow keys at the same time Cont...

Page 39: ...r the patient s body temperature if the unit is used on the patient with a oxygenator WARNING Do not operate the unit if The display has failed Individual segments of the tempera ture display have fai...

Page 40: ...49 7131 2706 345 Manufacturer medos Medizintechnik AG Obere Steinfurt 8 10 49 7131 2706 300 52222 Stolberg 49 7131 2706 498 GERMANY www xenios ag com info xenios ag com Distributor Xenios AG Im Zukun...

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