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STANDAR OPERASIONAL PROSEDUR
KALIBRASI RENATRON KALIBRASI RENATRON

(PAGI)
01 (PAGI)
Pasangkan CALIBRATION CELL
Tekan MUTE ALARM dan RESET bersamaan

Pilih Mode “00”
Tekan HOLD TO SET dan putar KNOP bersamaan

Pilih volume “254/255” ”
Tekan START PROCESS
Mesin akan ALARM pada STEP 35
Tekan MUTE ALARM

Volume yang terbaca :
67 ml - 73 ml
Tekan RESET
RENATRON SIAP MELAKUKAN REUSE
1
LANGKAH REPROCESSING
02 LANGKAH REPROCESSING
Pasangkan DIALYZER
(Dari Bawah Ke Atas)
Tekan HOLD TO SET dan putar KNOP bersamaan

Set 80% dari Total Volume Dialyzer (TCV)

Pilih Mode ”CH/HF” Mode CH (Low Flux Dialyzer)
KUF < 15
Mode HF (High Flux Dialyzer)
KUF ≥ 15
Mode 00 untuk Kalibrasi /
Sanitasi
Tekan START PROSES
Pada
PROCESS COMPLETE Step 57
Tekan RESET
Buka DIALYZER
(Dari Atas Ke Bawah)
2
SANITASI RENATRON SANITASI RENATRON

(SORE)
03 (sore)
Pasangkan CALIBRATION CELL

Pilih Mode “00”
Tekan START SANITIZE
Mesin akan pada STEP 83
SANITIZE COMPLITE
Tekan RESET dan OFF
BIARKAN MESIN SEKURANG-KURANGNYA 6 JAM

SEBELUM DIGUNAKAN
-
3
PREPARATION
(PERSIAPAN REUSE)
04 PREPARATION (PERSIAPAN REUSE)
1. Siapkan Renalin 100 konsentrasi 100 % (10 L) yang akan digunakan untuk sterilisasi dialyzer
dan hubungkan ke tubing/selang intake dari Renatron.
2. Siapkan Renalin 1 % (dicampur dengan air R.O) untuk sterilisasi Cap, RC connector dan
untuk membilas permukaan mesin Renatron (lihat prosedur)
3. Siapkan pelindung/proteksi seperti hand gloves/sarung tangan, kaca mata dan apron.
4. Nyalakan/putar kran RO, Cek tekanan/pressure air RO yang menuju ke Renatron sebagai
berikut :
a. Tekanan Statik (Static Pressure) = 20-55 Psi atau 1,38 – 3,79 Bar (baca penunjukan di pres-
sure gauge meter)
b. Tekanan Dinamik (dynamic pressure.) 30-35 Psi atau 2,07-2,41 bar (step atau langkah ke 4)
5. Cek tanggal kadaluarsa dari Renalin 100 (lihat pada galon renalin).
6. Lakukan kalibrasi sebelum melakukan proses sterilisasi dialyzer (1 kali dalam sehari/pagi
hari).
4
LANGKAH-LANGKAH LANGKAH-LANGKAH
05 KALIBRASI RENATRON
KALIBRASI RENATRON
1. Siapkan calibration cell, sambungkan calibration cell ke tubing arteri dan venous dari
mesin renatron (merah diatas & biru dibawah).
2. Perhatikan angka pada calibration cell (tertulis 70), artinya setelah proses kalibrasi mesin
harus menunjukkan angka 70, akurasi ± 3 (67 – 73).
3. Check tekanan/pressure pada Pressure Gauge Meter (static pressure 1,38 – 3,79 bar ).
4. Tekan tombol ON pada mesin, maka lampu indicator kuning akan menyala, dan di monitor
bagian depan muncul bacaan SEL dan --
5. Tekan dan tahan tombol MUTE dan RESET secara bersamaan, sampai di monitor
program step muncul angka 00
6. Tekan dan tahan tombol Hold to Set, putar kearah kanan tombol SET hingga volume
menunjukkan nilai 255 atau atur tombol SET pada nilai 255
7. Tekan tombol START PROCESS, maka kalibrasi dimulai.
8. Perhatikan pada step 4, maka tekanan pada Pressure Gauge akan menunjukkan 30-35 Psi
(2,07-2,41 bar)
9. Setelah proses kalibrasi selesai, alarm akan berbunyi dan pada monitor program step
muncul angka “35”
10. Perhatikan dan baca nilai volume yang ditunjukkan pada volume monitor, nilai yang
muncul pada display volume harus menunjukkan 70 ± 3m (67 ml – 73 ml).
11. Tekan tombol Mute Alarm untuk mematikan alarm dan tekan tombol RESET, maka mesin
siap dipakai untuk melakukan Reuse dialyser.
NOTE :
1. Jika pada proses kalibrasi, nilai volume tidak menunjukkan 70ml ± 3 (dibawah 67ml atau diatas 73 ml), maka
ulangi kembali proses kalibrasi menggunakan calibration cell.
2. Jika volume tetap tidak menunjukkan nilai 70ml ± 3, harap menghubungi teknisi.
3. Jika volume pada layar display volume menunjukkan angka 67ml s/d 73 ml, tetapi terjadi alarm “Volume Fail”,
hal ini dikarenakan mesin diset pada nilai 70 dan nilai aktual yang keluar dibawah nilai 70 ml ( 67ml-69ml)..
4. Selama nilai actual masih menunjukkan range antara 67ml – 73 ml, maka mesin masih bekerja dengan baik
dan lanjutkan proses reuse dialyzer.
5
PROSEDUR
REUSE DIALYZER
06
PROSEDUR REUSE DIALYZER
1. Sambungkan Dialyzer yang akan di-reuse ke Renatron, Kompartemen arteri (warna merah)
dari dialyzer menghadap keatas, dan kompartemen venous (warna biru) ada di bawah.
2. Sambungkan selang venous dari Renatron ke kompartemen venous dari dialyzer.
3. Sambungkan selang dialysate inlet dari Renatron ke kompartemen dialysate inlet pada dialy-
ser.
4. Sambungkan selang dialysate outlet dari Renatron (sanitize interlock) ke kompartemen dialy-
sate outlet pada dialyzer.
5. Terakhir, sambungkan selang arteri dari Renatron ke bagian arteri dari dialyzer.
6. Tekan dan tahan tombol Hold to Set, putar ke arah kanan tombol SET sesuai dengan 80% TCV
atau priming volume dari dialyzer yang akan di-reuse.
Misal : Dialyzer F6, dengan KUF 5,5 dan 100% priming volume 82 ml. Maka 80 % TCV-nya
adalah 66 ml.
Jadi putar tombol SET ke kanan sampai menunjukkan nilai/volume 66.
7. Tekan tombol MUTE dan RESET secara bersamaan untuk memilih mode dialyzer Ada 3
pilihan mode pada layar PROGRAM STEP, yaitu :
• CH  untuk dialyzer Low & intermediate Flux ( KUF ≤ 15 ).
• HF  untuk High Flux dialyzer ( KUF < 15.)
• 0  untuk mode kalibrasi dan Sanitasi.
8. Kemudian tekan tombol START PROCESS, maka proses sterilisasi dialyzer berlangsung
( lamanya ± 10 menit ).
9. Selama ± 10 menit proses tersebut, ada 3 proses yang dilakukan oleh Renatron, yaitu :
a. Cleaning Cycle (Fase Cleaning)  membersihkan kompartemen darah & dialysate
b. Testing Cycle (Fase Test )  test priming volume dan leak test
c. Desinfectan Cycle (Fase desinfectan)  disinfect kompartemen darah dan dialysate
dengan 3,5 % renalin
10. Setelah monitor PROGRAM STEP menunjukkan step 57, maka dilayar monitor muncul PRO-
CESS COMPLETTE dan alarm berbunyi.
11. Tekan tombol Mute Alarm, dan selanjutnya tekan tombol RESET.
12. Keluarkan dialyzer dari Renatron ( dari atas ke bawah ).
13. Bilas/seka dialyzer dengan 1 % Renalin, check apakah dialyzer telah terisi dengan Renalin
(minimum terisi oleh 2/3 renalin ).
14. Simpan dialyzer yang telah selesai di-reuse dalam lemari/tempat yang terlindung dari cahaya
matahari ( minimum 11 jam sebelum digunakan).
6
PERSIAPAN
RENALIN® 1%
07 PERSIAPAN RENALIN® 1%
• Merendam (disinfect) port cap (dialysate &arteri/vena) dan RC

• Connector Lap/bilas permukaan mesin Renatron®
Renalin® 100 Air R.O. Pencampuran Persentasi

100 % (ml) ( ml ) ( ml ) akhir (%)
1 20 21 1%
5 495 500 1%
10 990 1000 1%
20 1980 2000 1%
CATATAN :
1. Renalin® 1% yang telah dicairkan bekerja efektif maksimum : 24 Jam
2. Renalin® 1% ditempatkan dalam 2 wadah yang terpisah, 1 wadah untuk konektor yang kotor
dan wadah lainnya untuk konektor yang bersih.
7
SANITASI RENATRON
08 SANITASI RENATRON
1. Dilakukan 1 hari sekali ( shift terakhir setelah semua proses reuse selesai).
2. Siapkan Renalin 100 konsentrasi 100 % (10 L) yang akan digunakan untuk sterilisasi dialy-
ser.
3. Sama seperti pada proses kalibrasi, sambungkan Calibration Cell ke selang arteri dan
venous dari Renatron ( merah diatas & biru dibawah ).
4. Lakukan Bypass selang dialysate inlet dan outlet dari Renatron ke Sanitize Interlock.
5. Bersihkan seluruh permukaan Renatron dengan lap bersih yang sudah direndam dalam
larutan Renalin 1 %.
6. Pastikan bahwa pada monitor Volume menunjukkan bacaan SEL, dan pilih program mode
00.
7. Tekan tombol START SANITIZE, maka proses akan berlangsung ± 5 menit.
8. Setelah proses sanitasi selesai, alarm akan berbunyi dan di monitor muncul SANITIZE
COMPLETTE dan pada monitor PROGRAM STEP menunjukkan angka 83.
9. Tekan tomobol RESET dan tekan tombol OFF untuk mematikan mesin.
Diamkan mesin sekurang-kurangnya 6 jam sebelum dipakai kembali.
8
PROSEDUR MANUAL REUSE DIALYZER

09
PRECLEANING CLEANING
Drain Renalin 3.5%, 15’s
RO water, 6L/min, 15’s
Renalin 3.5%,
15’s Drain
s Setelah terisi Renalin 3.5%,

RO water, 6L/min, 15’s Drain
tutup kompartemen darah &
dialysate selama ± 10 mnt
Drain
kemudian bilas dengan RO
Bilas Kompartemen Bilas Kompartemen
Bilas Kompartemen Bilas Dialiser dengan Darah dari Arteri ke
Dialysate dari Arteri Darah dari Arteri ke renalindari Kompartemen
ke Vena & Vena ke Vena & Vena ke Arteri
Vena & Vena ke Arteri Dialysate dan biarkan
Arteri
9
kompartemen darah
terbuka
STERILISASI TESTING
Drain
PRESURE TEST VOLUME TEST
REUSE DIALYZER
Renalin 3.5%
PROSEDUR MANUAL
Negative pressure;
Drain -250mmHg
(-0,33bar)
Renalin 3.5%
(3X pengisian)
!!! Jika selama 30’s

terjadi penurunan
tekanan !!! Minimal
DOKUMENTASI & PENYIMPANAN 80% dari TCV
+25mmHg, berarti dialyzer total dialyzer
tidak bisa digunakan
Nama Hari/ Jenis Petugas
Reuse ke.. TCV 80% reuse Nama :
Pasien Tanggal Dialyzer
Reuse ke : __________
TCV : _____________
Nama :
Reuse ke :
TCV : _____________
Nama :
CLINICAL PROCEDURES
10 CLINICAL PROCEDURES
Manual Reuse Dengan Renalin

1. Precleaning
Pembilasan dengan air R.O. (Flush) :
• Lakukan flush atau pembilasan pada kompartemen darah dari arah arteri ke vena (atas ke
bawah).
• Kemudian lakukan pembilasan pada kompartemen dialysate dari bawah ke atas berlawanan
arah dengan kompartemen darah. Kemudian lakukan pembilasan dari atas ke bawah.
• Lakukanlah berulang-ulang secara bergantian. Untuk yang terakhir bersihkan dengan air R.O.
kompartemen darah dari vena ke arteri.
2. Cleaning/Pembersihan
Pembilasan dengan renalin 3,5% :
• Alirkan renalin yang sudah diencerkan dengan konsentrasi 3,5% untuk membilas komparte-
men dialysate dari bawah ke atas kemudian alirkan kembali renalin untuk membilas kompar-
temen dialysate dari atas ke bawah.
• Alirkan Renalin 3,5 % untuk membilas kompartemen darah dari arteri ke vena dan sebaliknya
(vena ke arteri). Alirkan terus Renalin atau diamkan selama ± 10 menit
3. Testing/ Pengujian
3.1. Test kebocoran membran dialyzer (Pressure Leak Test) :
• untuk mengetahui adanya kebocoran pada membrane (leak) dapat dilakukan secara manual
menggunakan pressure gauge dan balon karet seperti pada tensi meter manual.
• Pertama-tama hubungkan pressure gauge berikut balon karet ke kompartemen darah arteri.
Biarkan kedua kompartemen dialysate terbuka ke atmosphere
• Kosongkan air yang ada di kompartemen darah dan dialysate.
• Pada kompartemen darah vena sambungkan selang darah yang dihubungkan ke syringe 50
cc. Berikan tekanan ke kompartemen darah vena melalui syringe 50 cc ( 1 – 2 bar) sampai
meter (pressure gauge) menunjukkan nilai tertentu.
• Clamp selang darah yang terhubung ke syringe. Perhatikan penurunan tekanan pada pressure
gauge selama 1 menit.
3.2. Test FBV/TCV (Total Cell Volume) atau Priming Volume

• Menurut AAMI dialyzer dikatakan masih layak jika mempunyai TCV minimum 80 %
• Isi penuh kompartemen darah dengan air R.O. dan tutup ke 4 lubang pada kompartemen
darah dan dialysate dengan menggunakan tutup dialyzer. Siapkan gelas ukur 100 cc.
• Buka penutup kompartemen darah vena pada dialyzer, Letakkan dialyzer tepat diatas gelas
ukur dan biarkan air keluar dari dialyzer dan tampunglah pada gelas ukur 100 cc (jangan
sampai tumpah atau berceceran).
• Ukurlah berapa cc air yang tertampung di gelas ukur. Jika Total Volume air yang tertampung
minimum = 80 % priming volume dialyzer dari 100 % priming volume dialyzer baru, maka
dialyzer tersebut masik layak untuk dipakai.
10
4. Sterilisasi
Pengisian Dialyzer dengan larutan Sterilisasi/Renalin
• Setelah proses test selesai, lakukan pengisian renalin 3,5 % secara merata pada komparte-
men darah dan dialysate.
• Pengisian dilakukan mulai dari bawah (vena ke arteri) dan tidak boleh ada gelembung udara.
Sesuai dengan standard AAMI, bahwa pengisian sterilant atau disinfectant (renalin) haruslah 3
x volume dialyzer.
• Pertama isi kompartemen darah dan dialysate dengan renalin, setelah merata buka tutup
dialyzer dan biarkan renalin terbuang.
• Langkah kedua isi kembali dengan renalin dan kemudian buang kembali renalin.
• Langkah ketiga isi kembali kompartemen darah dan dialysate kemudian tutup dengan
kencang kompartemen darah dan dialysate dengan konektor yang sudah direndam dengan
renalin bersih 1 %.
• Periksa kedua kompartemen apakah sudah terisi penuh dan ada gelembung udara didalamn-
ya atau tidak.
• Bilaslah seluruh permukaan dialyzer dengan kain kasa yang sudah direndam dengan renalin
1 % bersih.
5. Dokumentasi dan Penyimpanan

5.1. Dokumentasi
• Cantumkan label stiker pada masing-masing dialyzer dan tulis nama pasien dan berapa kali
reuse.
• Catat di dalam buku reuse dalam bentuk tabel.
Jenis Petugas
Nama Pasien Hari/Tanggal Reuse ke.. TCV 80%
Dialyzer reuse
5.2. Penyimpanan
• Simpanlah dialyzer ditempat/lemari yang tertutup dan terlindung dari sinar matahari.
• Dialyzer diletakkan dengan kompartemen dialysate menghadap keatas.
• Disimpan minimum 11 jam sebelum digunakan ke pasien dan maksimum 4 minggu.
• Pisahkan antara dialyzer yang normal dan pasien yang posotif Hep C atau HIV.
• Setelah selesai melakukan reuse, petugas dialysis harus mencuci tangan dengan sabun
desinfectan.
11
Penyediaan 1% Renalin®
• Untuk merendam / disinfect port caps dan RC connectors.
• Untuk lap permukaan dialyzer dan mesin Renatron®.
Renalin® 100 / Jumlah /

Air (R.O) / ml Konsentrasi Akhir /%
ml ml
5 495 500 1%
10 990 1000 1%
20 1980 2000 1%
Peringatan!
Waktu kadaluarsa 1% Renalin® yang telah dicairkan: 24 Jam
Preparation of 3.5% Renalin® (from 100% Renalin)

• Disinfection of Dialyzers
® AAMI Quality Soluti on

Renalin 100 / ml Total / ml
Water (R.O) / ml concentration / %
35 965 1000 3.5%
70 1930 2000 3.5%
175 4825 5000 3.5%
350 9650 10000 3.5%
Masa kadaluarsa Renalin 3,5 % adalah 7 hari
12
13
14
15
RENALIN® 100 Cold Sterilant

Safety Data Sheet
according to Regulation (EC) No. 453/2010
SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1. Product identifier
® ® ®
Product name : RENALIN / RENALIN PA / RENALIN 100 Cold Sterilant
Product code : 78397-638,78397-639,78397-970,78398-060,78397-521,78397-741,78397-872
1.2. Relevant identified uses of the substance or mixture and uses advised against
1.2.1. Relevant identified uses
Main use category : Professional use
Use of the substance/mixture : Reprocessing of hemodialysis dialyzers
1.2.2. Uses advised against
No additional information available.
1.3. Details of the supplier of the safety data sheet
MEDIVATORS BV
Sourethweg 11
6422PC Heerlen - Netherlands
T (31) 45 5 471 471; 0800 894575 (UK)
csnl@medivators.com
1.4. Emergency telephone number
Emergency number : CHEMTREC International +1 (703) 527-3887 24 hr
SECTION 2: Hazards identification

2.1. Classification of the substance or mixture
Classification according to Regulation (EC) No. 1272/2008 [CLP] information + DPD classification in section 2.1
Ox. Liq. 1 H271
Org. Perox. G -
Met. Corr. 1 H290
Skin Corr. 1A H314
Eye Dam. 1 H318
Acute Tox. 4 (Inhalation) H332
STOT SE 3 H335
H336
Full text of H-phrases: see section 16

Classification according to Directive 67/548/EEC [DSD] or 1999/45/EC [DPD]
O; R7
Xn; R22
C; R34
Xi; R41
Full text of R-phrases: see section 16
Adverse physicochemical, human health and environmental effects

2.2. Label elements
Labelling according to Regulation (EC) No. 1272/2008 [CLP]
Hazard pictograms (CLP) :
GHS03 GHS05 GHS07

Signal word (CLP) : Danger
Hazard statements (CLP) : H271 - May cause fire or explosion; strong oxidiser.
H290 - May be corrosive to metals.
H314 - Causes severe skin burns and eye damage.
H332- Harmful if inhaled.
H335- May cause respiratory irritation.
H336- May cause drowsiness and dizziness.
Precautionary statements (CLP) : P210 - Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
50095-111-EN Rev A Date of issue: 19/02/2014 Revision Date: 19/02/2014

78397-638,78397-639,78397-970,78398-060,78397-521,78397-741,78397-872
16

Safety Data Sheet
P221 - Take any precaution to avoid mixing with combustibles (metals, oxidizing materials,
alkalis, caustics, chlorine, formaldehyde, salts, flammable organics).
P260 - Do not breathe dust/fume/gas/mist/vapours/spray.
P280 - Wear protective gloves/protective clothing/eye protection/face protection.
P303+P361+P353+P310 - IF ON SKIN (or hair): Take off immediately all contaminated
clothing. Rinse skin with water/shower. Immediately call a POISON CENTER/doctor.
P304+P340+ P311 - IF INHALED: Remove person to fresh air and keep comfortable for
breathing. Call a POISON CENTER/doctor.
P305+P351+P338+ P310 - IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a
POISON CENTER/doctor.
P371 + P380 + P375 - In case of major fire and large quantities: Evacuate area. Fight fire
remotely due to the risk of explosion.
P403 + P233 - Store in a well-ventilated place. Keep container tightly closed.
2.3. Other hazards

SECTION 3: Composition/information on ingredients

3.1. Substance
Not applicable.
3.2. Mixture
Name Product identifier % Classification according to
Regulation (EC) No.
1272/2008 [CLP]
Hydrogen peroxide (CAS No) 7722-84-1 10 - 30 Ox. Liq. 1, H271
(EC no) 231-765-0 Acute Tox. 4 (Oral), H302
(EC index no) 008-003-00-9 Acute Tox. 4 (Inhalation), H332
Skin Corr. 1A, H314 (C >= 70)
Acetic acid (CAS No) 64-19-7 5 - 10 Flam. Liq. 3, H226
(EC no) 200-580-7 Acute Tox. 4 (Dermal), H312
(EC index no) 607-002-00-6 Skin Corr. 1A, H314 (C >= 90)
Peroxyacetic acid (CAS No) 79-21-0 3-7 Flam. Liq. 3, H226
(EC no) 201-186-8 Org. Perox. D, H242
(EC index no) 607-094-00-8 Acute Tox. 4 (Oral), H302
Acute Tox. 4 (Dermal), H312
Acute Tox. 4 (Inhalation), H332
Skin Corr. 1A, H314
STOT SE 3, H335
Aquatic Acute 1, H400
Stabilizer Proprietary 0.5 – 1.5 Eye Dam. 1, H318
Met. Corr. 1, H290
Name Product identifier % Classification according to

Directive 67/548/EEC
Hydrogen peroxide (CAS No) 7722-84-1 10 - 30 O; R8
(EC no) 231-765-0 Xn; R20 (C >= 50)
(EC index no) 008-003-00-9 Xn; R22
C; R35 (C >= 70)
R5
Acetic acid (CAS No) 64-19-7 5 - 10 R10
(EC no) 200-580-7 Xn; R21
(EC index no) 607-002-00-6 C; R35 (C >= 90)
Peroxyacetic acid (CAS No) 79-21-0 3-7 R10
(EC no) 201-186-8 O; R7
(EC index no) 607-094-00-8 Xn; R20/21/22
C; R35
N; R50
Stabilizer Proprietary 0.5 – 1.5 Xi; R41
Full text of R- and H-phrases: see section 16
SECTION 4: First aid measures

4.1. Description of first aid measures
First-aid measures after inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult,
give oxygen. Get immediate medical advice/attention.
First-aid measures after skin contact : In case of contact, immediately flush skin with plenty of water. Remove contaminated clothing
and shoes. Wash clothing before reuse. Get immediate medical advice/attention.
First-aid measures after eye contact : In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. If easy to
do, remove contact lenses, if worn. Get immediate medical advice/attention.
First-aid measures after ingestion : Do NOT induce vomiting. Rinse mouth. Never give anything by mouth to an unconscious
person. Get immediate medical advice/attention.

78397-638,78397-639,78397-970,78398-060,78397-521,78397-741,78397-872
17

Safety Data Sheet
4.2. Most important symptoms and effects, both acute and delayed
Symptoms/injuries after inhalation : Harmful if inhaled. May cause respiratory irritation. May cause dizziness or drowsiness.
Symptoms/injuries after skin contact : Causes severe skin burns. Symptoms may include redness, pain, blisters.
Symptoms/injuries after eye contact : Causes serious eye damage. Symptoms may include discomfort or pain, excess blinking and
tear production, with marked redness and swelling of the conjunctiva. May cause burns.
Symptoms/injuries after ingestion : May be harmful if swallowed. May cause stomach distress, nausea or vomiting. May cause
burns to the linings of the mouth, throat, and gastrointestinal tract.
4.3. Indication of any immediate medical attention and special treatment needed
Symptoms may not appear immediately. In case of accident or if you feel unwell, seek medical advice immediately (show the label or SDS where possible).
SECTION 5: Firefighting measures

5.1. Extinguishing media
Suitable extinguishing media : Water spray, dry chemical, foam, carbon dioxide.
Unsuitable extinguishing media : Do not use water jet.
5.2. Special hazards arising from the substance or mixture
Fire hazard : Products of combustion may include, and are not limited to: oxides of carbon, oxygen. Danger
of developing toxic pyrolyse products.
Explosion hazard : Heat may build pressure, rupturing closed containers, spreading fire and increasing risk of
burns and injuries. This material increases the risk of fire and may aid combustion.
5.3. Advice for firefighters
Protection during firefighting : Keep upwind of fire. Wear full fire fighting turn-out gear (full Bunker gear) and respiratory
protection (SCBA). Use water spray to cool exposed surfaces.
SECTION 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures
General measures : Use personal protection recommended in Section 8. Isolate the hazard area and deny entry to
unnecessary and unprotected personnel. Remove ignition sources.
6.2. Environmental precautions
Relevant water authorities should be notified of any large spillage to water course or drain.
6.3. Methods and material for containment and cleaning up
For containment : In case of accidental spillage, contain the spill and neutralize it with sodium bicarbonate or
sodium carbonate. Use appropriate personal protection equipment (PPE).
Methods for cleaning up : Scoop up material and place in a disposal container. Absorb spillage to prevent material
damage. Provide ventilation. Do not reuse the liquid material.
6.4. Reference to other sections
See section 8 for further information on protective clothing and equipment and section 13 for advice on waste disposal.
SECTION 7: Handling and storage

7.1. Precautions for safe handling
Additional hazards when processed : May be corrosive to metals.
Precautions for safe handling : Keep away from sources of ignition. Do not get in eyes, on skin, or on clothing. Do not breathe
dust/fume/gas/mist/vapors/spray. Do not swallow. Handle and open container with care. Use
only outdoors or in a well-ventilated area. When using do not eat, drink or smoke. Never return
unused material to original container.
Hygiene measures : Launder contaminated clothing before reuse. Wash hands before eating, drinking, or smoking.
7.2. Conditions for safe storage, including any incompatibilities
Technical measures : Proper grounding procedures to avoid static electricity should be followed.
Storage conditions : Keep out of the reach of children. Keep container tightly closed. Keep only in the original
container in a cool, well-ventilated place. Store away from other materials. Floor needs a
protective coating against acid. Store at temperatures not exceeding 23.9 °C (75 °F). Protect
from sunlight. Store locked up.
7.3. Specific end use(s)
Not available.
SECTION 8: Exposure controls/personal protection
8.1. Control parameters
Hydrogen peroxide (7722-84-1)
United Kingdom WEL TW A (mg/m³) 1.4 mg/m³
United Kingdom WEL TW A (ppm) 1 ppm
United Kingdom WEL STEL (mg/m³) 2.8 mg/m³

78397-638,78397-639,78397-970,78398-060,78397-521,78397-741,78397-872
18

Safety Data Sheet

United Kingdom WEL STEL (ppm) 2 ppm
Acetic acid (64-19-7)
EU IOELV TW A (mg/m³) 25 mg/m³
EU IOELV TW A (ppm) 10 ppm
8.2. Exposure controls

Appropriate engineering controls : Use ventilation adequate to keep exposures (airborne levels of dust, fume, vapor, etc.) below
recommended exposure limits. Ensure that eyewash stations and safety showers are close to
the workstation location.
Hand protection : Wear chemically resistant protective gloves.
Eye protection : Wear approved eye protection (properly fitted dust- or splash-proof chemical safety goggles)
and face protection (face shield).
Skin and body protection : Wear suitable protective clothing. Wear solvent resistant apron and boots for spills.
Respiratory protection : In case of insufficient ventilation, wear suitable respiratory equipment. Respirator selection
must be based on known or anticipated exposure levels, the hazards of the product and the
safe working limits of the selected respirator.
Environmental exposure controls : Maintain levels below Community environmental protection thresholds.
Other information : Do not eat, smoke or drink where material is handled, processed or stored. Wash hands carefully
before eating or smoking. Handle according to established industrial hygiene and safety practices.
SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties
Physical state : Liquid
Appearance : Clear
Colour : Colourless
Odour : Acidic
Odour threshold : No data available
pH : 0.8 +/- 3
Relative evaporation rate (butylacetate=1) : No data available
Melting point : No data available
Freezing point : No data available
Boiling point : No data available
Flash point : No data available
Auto-ignition temperature : No data available
Decomposition temperature : No data available
Flammability (solid, gas) : Not flammable
Vapour pressure : No data available
Relative vapour density at 20 °C : No data available
Relative density : 1.09 - 1.14
Solubility : No data available
Partition coefficient: n-octanol/water : No data available
Log Pow : No data available
Viscosity, kinematic : No data available
Viscosity, dynamic : No data available
Explosive properties : No data available
Oxidising properties : Strong oxidiser
Explosive limits : No data available
SADT : >60°C
9.2. Other information
SECTION 10: Stability and reactivity

10.1. Reactivity
May cause or contribute to the combustion of other material generally by yielding oxygen. May be corrosive to metals.
10.2. Chemical stability
Stable under normal storage conditions. Decomposes slowly to release oxygen.
10.3. Possibility of hazardous reactions
No dangerous reaction known under conditions of normal use.

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Safety Data Sheet
10.4. Conditions to avoid

Heat. Sources of ignition. Incompatible materials.
10.5. Incompatible materials
Metals. Oxidizing materials. Alkalis. Caustics. Chlorine. Formaldehyde. Salts. Flammable organics.
10.6. Hazardous decomposition products
May include, and are not limited to: oxides of carbon, oxygen. Do not mix with chlorinated products as this could liberate toxic corrosive chlorine gas.
SECTION 11: Toxicological information

11.1. Information on toxicological effects
Acute toxicity : Harmful if inhaled.
RENALIN 100 Cold Sterilant

LD50 oral rat > 2000 mg/kg
LD50 dermal rabbit > 2000 mg/kg
LC50 inhalation rat >2.0 but ≤10.0 mg/l (Calculated using ATE values)

LD50 oral rat 801 mg/kg
LD50 dermal rat 4060 mg/kg
LD50 dermal rabbit 2000 mg/kg
LC50 inhalation rat 2 g/m³/4 h
LD50 dermal rabbit 1060 mg/kg
Peroxyacetic acid (79-21-0)
LD50 dermal rabbit 1410 µl/kg
LC50 inhalation mouse 0.524 mg/l4/h
Stabilizer (Proprietary)
LD50 dermal rabbit > 7940 mg/kg
Skin corrosion/irritation : Causes severe skin burns.
Serious eye damage/irritation : Causes serious eye damage.
Respiratory or skin sensitisation : Based on available data, the classification criteria are not met.
Germ cell mutagenicity : Based on available data, the classification criteria are not met.
Carcinogenicity : Based on available data, the classification criteria are not met.
Reproductive toxicity : Based on available data, the classification criteria are not met.
Specific target organ toxicity (single exposure) : Based on available data, the classification criteria are not met.
Specific target organ toxicity (repeated exposure) : Based on available data, the classification criteria are not met.
Aspiration hazard : Based on available data, the classification criteria are not met.
Other information : May cause respiratory irritation, dizziness, or drowsiness.
SECTION 12: Ecological information

12.1. Toxicity
Ecology - general : Not considered to be harmful to aquatic life.

LC50 fishes 1 16.4 mg/l (96 h - Pimephales promelas)
EC50 Daphnia 1 18 - 32 mg/l 48 h - Daphnia magna [Static])
LC50 fish 2 18 - 56 mg/l (96 h - Lepomis macrochirus [static])
LC50 fishes 1 79 mg/l (96 h - Pimephales promelas [static])
EC50 Daphnia 1 65 mg/l (48 h - Daphnia magna [Static])
LC50 fish 2 75 mg/l (96 h - Lepomis macrochirus [static])
LC50 fishes 1 868 mg/l (96 h - Lepomis macrochirus [static])
EC50 Daphnia 1 527 mg/l (48 h - Daphnia magna)
LC50 fish 2 360 mg/l (96 h - Oncorhynchus mykiss [static])
NOEC (acute) 1000 mg/kg (14 Days - Eisenia foetida [soil dry weight])

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Safety Data Sheet
12.2. Persistence and degradability

12.3. Bioaccumulative potential
RENALIN 100 Cold Sterilant
Bioaccumulative potential Not established.
BCF fish 1 (no bioaccumulation)
Log Pow -0.31 (at 20 °C)
Peroxyacetic acid (79-21-0)
BCF fish 1 (not bioaccumulative, rapid degradation)
BCF fish 1 < 50
Log Pow 3.49
12.4. Mobility in soil
12.5. Results of PBT and vPvB assessment
12.6. Other adverse effects

SECTION 13: Disposal considerations

13.1. Waste treatment methods
Waste disposal recommendations : This material must be disposed of in accordance with all local, state, provincial, and federal
regulations. The generation of waste should be avoided or minimized wherever possible.
SECTION 14: Transport information
In accordance with ADR.
14.1. UN number
UN-No. (ADR) : 3149
14.2. UN proper shipping name
Proper Shipping Name (ADR) : HYDROGEN PEROXIDE AND PEROXYACETIC ACID MIXTURE, STABILIZED
14.3. Transport hazard class(es)
Class (ADR) : 5.1 (8)
Danger labels (ADR) :
14.4. Packing group

Packing group (ADR) : II
14.5. Environmental hazards
Dangerous for the environment : No.
Marine pollutant : No.
Other information : No supplementary information available.
14.6. Special precautions for user
Special transport precautions : Do not handle until all safety precautions have been read and understood.
14.7. Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
No additional information.
SECTION 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
15.1.1. EU-Regulations
Contains no substances with Annex XVII restrictions.
Contains no REACH candidate substance.
Contains no REACH Annex XIV substances.
15.1.2. National regulations
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Safety Data Sheet
15.2. Chemical safety assessment

No chemical safety assessment has been carried out.
SECTION 16: Other information

Indication of changes:
None.
Data sources : REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and
mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006.
Other information : None.
Full text of R-, H- and EUH-phrases:
Acute Tox. 4 (Dermal) Acute toxicity (dermal), Category 4
Acute Tox. 4 (Inhalation) Acute toxicity (inhal.), Category 4
Acute Tox. 4 (Oral) Acute toxicity (oral), Category 4
Eye Dam. 1 Serious eye damage/eye irritation, Category 1
Flam. Liq. 3 Flammable liquids, Category 3
Met. Corr. 1 Corrosive to metals, Category 1
Org. Perox. G Organic Peroxides, Type G
Ox. Liq. 1 Oxidising Liquids, Category 1
Skin Corr. 1A Skin corrosion/irritation, Category 1A
STOT SE 3 Specific target organ toxicity - Single exposure, Category 3
H226 Flammable liquid and vapour
H271 May cause fire or explosion; strong oxidiser
H290 May be corrosive to metals
H302 Harmful if swallowed
H312 Harmful in contact with skin
H314 Causes severe skin burns and eye damage
H318 Causes serious eye damage
H332 Harmful if inhaled
H335 May cause respiratory irritation
H336 May cause drowsiness or dizziness
H400 Very toxic to aquatic life
R10 Flammable
R20/21/22 Harmful by inhalation, in contact with skin and if swallowed
R20/22 Harmful by inhalation and if swallowed
R21 Harmful in contact with skin
R22 Harmful if swallowed
R34 Causes burns
R35 Causes severe burns
R41 Risk of serious damage to eyes
R5 Heating may cause an explosion
R50 Very toxic to aquatic organisms
R7 May cause fire
R8 Contact with combustible material may cause fire
C Corrosive
N Dangerous for the environment
O Oxidising
Xi Irritant
Xn Harmful
Classification and procedure used to derive the classification for mixtures according to Regulation (EC) 1272/2008 [CLP]:
Ox. Liq. 1 H271 Expert judgment
Org. Perox. G - Expert judgment
Met. Corr. 1 H290 Expert judgment
Acute Tox. 4 (Inhalation) H332 Calculation method
Skin Corr. 1A H314 On basis of test data/Concentration limits
Eye Dam. 1 H318 Concentration limits

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Safety Data Sheet
Disclaimer: We believe the statements, technical information and recommendations contained herein are reliable, but they are given without warranty or guarantee of any kind. The information
contained in this document applies to this specific material as supplied. It may not be valid for this material if it is used in combination with any other materials. It is the user’s responsibility to satisfy
oneself as to the suitability and completeness of this information for the user’s own particular use.

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Dialyzer Priming Volume

Manufacturer Model Priming 80% of KUF/ (ml Program
No. Volume Priming h/mmHg) Mode
Volume
1 Fresenius F5 HPS 10 CH
2 Fresenius F6 HPS 78 62 13 CH
3 Fresenius F7 HPS 96 77 16 HF
4 Fresenius F8 HPS 113 90 18 HF
5 Nipro 110 T 75 60 4,7 CH
6 Nipro 130 T 85 68 5,6 CH
7 Baxter CAHP 90 60 48 3,9 CH
10 Baxter CAHP 170 105 84 10 CH
11 Baxter BLS 517 G 99 79 17 HF
12 Idemsa 20 H 63 50 4,7 CH
13 BBraun Diacap® LO PS 10 58 46 6,8 CH
14 Bbraun Diacap® LO PS 12 68 54 7,9 CH
18 Bbraun Diacap Pro 13 H 80 64 70 HF
19 Elisio 130 M 80 64 17 HF
20 150 M 91 73 20 HF
21 170 M 108 86 22 HF
22 190 M 115 92 25 HF
23 210 M 128 102 27 HF
24 Rexed 13 L 76 61 11 CH
25 15 L 86 69 12 CH
26 Toray CS-1.3U 81 64 41 HF
27 CS-1.6U 97 77 46 HF
28 CS-1.8U 108 86 47 HF
29 CS-2.1U 126 100 53 HF
30 TS 1,6 SL / 1, 6 UL 95 76 49 HF
31 Elisio 09 H 62 50 53 HF
32 11 H 70 56 59 HF
33 13 H 85 68 64 HF
34 15 H 95 76 67 HF
35 17 H 105 84 74 HF
36 Bellco BLS512SD 77 61 22 HF
37 BLS514SD 85 68 26 HF
38 BLS517SD 99 79 32 HF
39 BLS520SD 123 98 38 HF
40 BLS 517G 99 79 17 HF
41 Allmed Polypure 13 69 55 10,5 CH
42 Polypure 16 86 69 12,9 CH
43 Polypure 18 105 84 14,6 CH
44 Polypure 13 S 69 55 14,7 CH
45 Polypure 16 S 86 69 17,1 HF
46 Polypure 18 S 105 84 19,2 HF
47
48
24

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KALIBRASI RENATRON KALIBRASI RENATRON

Pasangkan CALIBRATION CELL

Tekan MUTE ALARM dan RESET bersamaan

Tekan HOLD TO SET dan putar KNOP bersamaan

Tekan START PROCESS

Mesin akan ALARM pada STEP 35

Tekan MUTE ALARM

RENATRON SIAP MELAKUKAN REUSE

Tekan HOLD TO SET dan putar KNOP bersamaan

Tekan MUTE ALARM dan RESET bersamaan

Tekan START PROSES

SANITASI RENATRON SANITASI RENATRON

Pasangkan CALIBRATION CELL

Tekan MUTE ALARM dan RESET bersamaan

Tekan START SANITIZE

Mesin akan pada STEP 83

Tekan RESET dan OFF

BIARKAN MESIN SEKURANG-KURANGNYA 6 JAM

7. Tekan tombol START PROCESS, maka kalibrasi dimulai.

2. Sambungkan selang venous dari Renatron ke kompartemen venous dari dialyzer.

12. Keluarkan dialyzer dari Renatron ( dari atas ke bawah ).

• Merendam (disinfect) port cap (dialysate &arteri/vena) dan RC

Renalin® 100 Air R.O. Pencampuran Persentasi

7. Tekan tombol START SANITIZE, maka proses akan berlangsung ± 5 menit.

Diamkan mesin sekurang-kurangnya 6 jam sebelum dipakai kembali.

PROSEDUR MANUAL REUSE DIALYZER

s Setelah terisi Renalin 3.5%,

!!! Jika selama 30’s

Manual Reuse Dengan Renalin

3.2. Test FBV/TCV (Total Cell Volume) atau Priming Volume

5. Dokumentasi dan Penyimpanan

Renalin® 100 / Jumlah /

Preparation of 3.5% Renalin® (from 100% Renalin)

® AAMI Quality Soluti on

35 965 1000 3.5%

70 1930 2000 3.5%

175 4825 5000 3.5%

350 9650 10000 3.5%

Masa kadaluarsa Renalin 3,5 % adalah 7 hari

RENALIN® 100 Cold Sterilant

SECTION 1: Identification of the substance/mixture and of the company/undertaking

SECTION 2: Hazards identification

Acute Tox. 4 (Inhalation) H332

Full text of H-phrases: see section 16

Adverse physicochemical, human health and environmental effects

GHS03 GHS05 GHS07

50095-111-EN Rev A Date of issue: 19/02/2014 Revision Date: 19/02/2014

RENALIN® 100 Cold Sterilant

2.3. Other hazards

SECTION 3: Composition/information on ingredients

Name Product identifier % Classification according to

Full text of R- and H-phrases: see section 16

SECTION 4: First aid measures

50095-111-EN Rev A Date of issue: 19/02/2014 Revision Date: 19/02/2014

RENALIN® 100 Cold Sterilant

SECTION 5: Firefighting measures

SECTION 6: Accidental release measures

SECTION 7: Handling and storage

50095-111-EN Rev A Date of issue: 19/02/2014 Revision Date: 19/02/2014

RENALIN® 100 Cold Sterilant

Hydrogen peroxide (7722-84-1)

8.2. Exposure controls