Instruction Manual for FRESENIUS MEDICAL models including: AV 400S, AV 600S, AV 1000S, AV Series Ultraflux Disposables and Fluids, AV Series, Ultraflux Disposables and Fluids, Disposables and Fluids, Fluids
Ultraflux® AV 400S / 600S / 1000S
Capillary Haemofilters for Continuous Renal Replacement Therapies CAVH(D), CVVH(D), CVVHDF, High-Volume CVVH (HV-CVVH)
Technical Data
Art. No.
AV 400S
5007341
AV 600S
5007361
AV 1000S
5008981
S (sieving coefficient)
Membrane material Inner lumen Wall thickness
Vit. B12 Inulin
E2-M Albumin
1 1 0.65 0.001
Fresenius Polysulfone® 220 m 35 m
Sterilisation method
INLINE steam
Blood connectors Filtrate- / dialysate connectors
acc. to EN 1283, ISO 8637
Max. filtrate flow TMP max. Recommended blood flow range V (priming volume) blood / filtrate
P (pressure drop) blood, Hct. 45% A (effective surface area) Recommended period of use
20% of effective blood flow
600 mm Hg
D 50 - 200 mL/min
100 350 mL/min
200 500 mL/min
52 mL / 135 mL
100 mL / 210 mL
130 mL / 300 mL
50 mmHg (QB=100 mL/min) 45 mmHg (QB=200 mL/min) 52 mmHg (QB=300 mL/min)
E 0.7 m²
1.4 m²
1.8 m²
Kmax. 72 hours
,QYLWUR data are likely to differ from LQYLYR data due to the patient's blood composition and clinical settings.
Preferable Flow Directions
Recommended Blood Flow Range
O (HV-)CVVH
CVVHD(F)
2
V Blood out
Blood in
AV 1000 S
E 1,6
Filtrate out
R Dialysate out
AV 600 S
1,2
Surface Area [m²]
Dialysate cap AV -
Filter
Dialysate in
Blood in
Blood out
0,8 AV 400 S
0,4
0 0 100 200 300 400 500
Blood Flow [mL/min]
,--
~
a
-r
FRESENIUS MEDICAL CARE
Fresenius Medical Care AG & Co. KGaA 61346 Bad Homburg, Germany
{j) +49 6172 609-0
CGB) Instructions for Use
Ultraflux® AV 400 S / AV 600 S / AV 1000 S
Capillary Haemofilter for Continuous Renal Replacement Therapies
GENERAL NOTES
PERFORMANCE OF TREATMENT
Refer to product or carton label for:
® Single use only
lsrERI~
Blood pathway sterile. Steam sterilised
Priming For priming the Ultraflux® AV-filter must be filled with isotonic saline solution and has to be de-aerated. Once this is achieved no further rinsing is required.
~
Expiry date
&
Refer to instructions for use
The detailed priming procedure depends on the equipment used and the instructions provided with the acute dialysis machine have to be followed. In general the following recommendations are valid:
[ill] Batch
~
Order number
CVVH: The arterial blood inlet should preferably be located at the lower end and the venous blood outlet at the upper end of the filter. The
d
Date of manufacture
~
Units
%+30°C
+ 5 °C
·UF Control
Storage temperature range
Use only on machines with exact UF-control
filtrate should be withdrawn at the upper filtrate port whereas the lower filtrate port remains closed with the closure cap (see drawing).
CVVHD(F): For enhanced effectiveness blood and dialysate should be in counter-current flow with blood inlet at the upper end and blood outlet at the lower end of the dialyser whereas the dialysate inlet is at the lower end and the dialysate outlet at the upper end of the dialyser (see
Indication: Ultraflux® AV-filters are designed for single use in acute
drawing).
dialysis with machine-assisted continuous veno-venous haemofiltration, haemodialysis and haemodiafiltration (CVVH, CVVHD, CVVHDF).
Patient connection
AV 1000 S is specifically recommended for High-Volume CVVH / CVVHDF.
The detailed procedure depends on the dialysis system utilised and the
Ultraflux® AV-filters 400S and 600S are also suitable for a non-machine assisted continuous arterio-venous haemofiltration or haemodialysis (CAVH, CAVHD).
Contra-indications: Contra-indications are unknown. Generally, contra-indications for acute dialysis are applicable.
Side effects: In rare cases hypersensitivity reactions may occur during acute dialysis treatment. In severe cases dialysis must be discontinued and the appropriate medication initiated.
The filter is steam-sterilised and thus contains no sterilisation residues.
Anticoagulation: It is recommended to introduce an anticoagulant to the extracorporeal blood circuit during priming and treatment. Nature, amount and method of application of an anticoagulant must be prescribed by the responsible physician in consideration to the patient's
instructions provided with the machine have to be followed. In general the following notes are valid:
Connect the arterial blood tubing system to the patient's blood circulation. Avoid entry of air. Allow the blood to flow into blood tubing system and filter until nearly all the saline solution is expelled
D (recommended pump setting approx. 100 mL/min).
At the beginning of the treatment it is recommended to circulate the blood for approximately 3 min without filtration. Subsequently adjust treatment parameters to desired settings.
E Inspect again all connections and components for leaks and
proper fitting .
KSubstitution of the filtrate volume
condition (e.g. initial heparin bolus of 30-50 IU/kg BW followed by a continuous dose of 5-20 IU/h/kg BW). For a body weight of 70 kg this corresponds to an initial dose of 2000-3500 IU followed by a continuous dose of 350-1400 IU/h.
Coagulation should be monitored at regular intervals (e.g. hourly
O measurement of the activated clotting time ACT or partial
thromboplastin time PTT). Particularly for patients with a tendency to bleed we recommend regular control by means of the ACT and/or PTT. Materials: Membrane: Fresenius Polysulfone®,
V Housing: Polycarbonate, potting material: Polyurethane, O-ring: silicone
Further information may be obtained on request.
E WARNINGS
Continuous renal replacement therapies require careful monitoring of the patient. Therefore a dialysis system equipped with the appropriate safety devices such as a blood leak detector, pressure monitors, an air
R detector etc.. should be used.
Depending on the desired fluid removal the filtrate volume can be substituted either completely or partly with haemofiltration solution. The substitution solution can be administered into extracorporeal circuit either upstream of the filter (predilution) or downstream of the filter (postdilution). Ensure an exact fluid balancing of the filtrate and substituate volume.
Recommendation for postdilution CVVH and postdilution CVVHDF
If the blood water content is reduced too much, the risk of clotting in the extracorporeal circuit increases. Therefore it is advisable to keep the blood water content within a certain uncritical range. We recommend to set the maximal total filtrate flow (= exchange rate filtrate/substituate + water removal rate) to 20% of the blood flow.
If higher substitution volumes are required, the substitution solution should be administered in the predilution mode.
Exchange of Ultraflux® AV-filter
If the filter is clotted (irregular colouring of the capillaries, persistent TMP alarm) or if the filter shows a blood leak (red colouring of the filtrate) the filter must be exchanged. Whether it is possible to reinfuse
An exact recording of the ultrafiltration volume and the balancing of the
the blood with saline solution (for example 250 mL bag) must be
substitution and filtrate volume must be guaranteed by a suitable
decided by the attending physician.
system. To ensure correct handling of the Ultraflux® AV-filters during priming,
In general during longer lasting treatments it is recommended to exchange the Ultraflux® AV-filter together with the blood lines after
performing and termination of the treatment the instructions provided
a maximal use of 72 hours.
with the dialysis machine (e.g. multiFiltrate, ADM 08 / ABM) should be
followed.
Termination of treatment
Use only if unit package is intact, sealing caps are in place and the Ultraflux® AV-filter is undamaged. Ultraflux® AV-filters must not be used after the expiry date (see label). Each Ultraflux® AV-filter is checked for integrity prior to leaving the factory. If a blood leak should arise, the filter must be exchanged. The Ultraflux® AV-filter is intended for single-use only. Re-use may be hazardous to both the patient and operator. Cleansing solutions and disinfectants may damage materials employed for the housing, potting and membrane. Safety of use can no longer be guaranteed and the manufacturer assumes no liability.
For the termination of the treatment refer to the instructions for use of the dialysis machine used. The blood should be completely reinfused to the patient using saline solution (e.g. 250 mL bag, pump setting approx. 100 mL/min).
WARRANTY Products with proven manufacturing defects will be replaced if the defect is reported stating the lot number. The manufacturer will not be liable for any misuse, improper handling, non-compliance with instructions for use and cautionary notes and for any damage incurred subsequent to the manufacturer's delivery of the filter.
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